Medtronic Vascular

Complete recall history across all FDA and CPSC categories — 211 total recalls

Medtronic Vascular appears in recall records across 1 category. This page consolidates all FDA food, drug, and medical device enforcement actions, plus CPSC consumer product recalls associated with this company. Recall data is sourced from openFDA and CPSC public databases.

Device Recalls (211)

FDA medical device enforcement actions by Medtronic Vascular. Showing most recent 50.

Date Product Reason Class
May 4, 2021 Angiographic Guidewire Component: Model Number: 107042, 107044, 107447, 11000... The component part numbers intended for shipment to a third-party, where they... Class I
Jan 15, 2021 Medtronic 6F Launcher Guide Catheter 100 cmJL 3.5 Model Number: LA6JL35 Sterility may be compromised due to an unsealed pouch Class II
Jan 15, 2021 Medtronic 6F Launcher Guide Catheter 100 cm JR 4.0 Model Number: LA6JR40 Sterility may be compromised due to an unsealed pouch Class II
Jan 15, 2021 Medtronic 6F Launcher Guide Catheter 100cm EBU 3.75 Model Number: LA6EBU375 Sterility may be compromised due to an unsealed pouch Class II
Jan 15, 2021 Medtronic 6F Launcher Guide Catheter 100 cm EBU 3.0 Model Number: LA6EBU30 Sterility may be compromised due to an unsealed pouch Class II
Aug 25, 2020 Rashkind Balloon Septostomy Catheter, 5F, Closed end, 50 cm, Pediatric, Singl... Subsequent failure of catheters in the field and failed quality testing Class I
Aug 25, 2020 Rashkind Balloon Septostomy Catheter, 4F, Closed end, 50 cm, Pediatric, Singl... Subsequent failure of catheters in the field and failed quality testing Class I
Aug 25, 2020 Rashkind Balloon Septostomy Catheter, 6F, Recess Balloon, Closed end, 50 cm, ... Subsequent failure of catheters in the field and failed quality testing Class I
Mar 15, 2019 SHERPA NX ACTIVE GUIDING CATHETER, 6F, AR2.0, 100CM.070", REF SA6AR20. for ... There is a potential for extensive loss of primary segment material exposing ... Class I
Mar 15, 2019 SHERPA NX ACTIVE GUIDING CATHETER, 6F, RCB SH, 90CM, 070", REF SA6RCBSHD. f... There is a potential for extensive loss of primary segment material exposing ... Class I
Mar 15, 2019 SHERPA NX ACTIVE GUIDING CATHETER, 6F LCB SH, .070", REF SA6LCBSH. for card... There is a potential for extensive loss of primary segment material exposing ... Class I
Mar 15, 2019 SHERPA NX ACTIVE GUIDING CATHETER, 6F MP ST, .070", REF SA6MPST. for cardio... There is a potential for extensive loss of primary segment material exposing ... Class I
Mar 15, 2019 SHERPA NX ACTIVE GUIDING CATHETER, 6F, AR1.0SH 100CM.070", REF SA6AR10SH. f... There is a potential for extensive loss of primary segment material exposing ... Class I
Mar 15, 2019 SHERPA NX ACTIVE GUIDING CATHETER, 6F JL4.5, .070", REF SA6JL45. for cardio... There is a potential for extensive loss of primary segment material exposing ... Class I
Mar 15, 2019 SHERPA NX ACTIVE GUIDING CATHETER, 6F, AR1.0 100CM.070", REF SA6AR10. for c... There is a potential for extensive loss of primary segment material exposing ... Class I
Mar 15, 2019 SHERPA NX ACTIVE GUIDING CATHETER, 6F, AL1.0 110CM .070", REF SA6AL10A. for... There is a potential for extensive loss of primary segment material exposing ... Class I
Mar 15, 2019 SHERPA NX ACTIVE GUIDING CATHETER, 6F, NOTO, 100CM, 070", REF SA6NOTO. for ... There is a potential for extensive loss of primary segment material exposing ... Class I
Mar 15, 2019 SHERPA NX ACTIVE GUIDING CATHETER, 6F RBU4.0 SH, .070", REF SA6RBU40SH. for... There is a potential for extensive loss of primary segment material exposing ... Class I
Mar 15, 2019 SHERPA NX ACTIVE GUIDING CATHETER, 6F, RBU3.5, 100CM, 070", REF SA6RBU35. f... There is a potential for extensive loss of primary segment material exposing ... Class I
Mar 15, 2019 SHERPA NX ACTIVE GUIDING CATHETER, 6F ERAD LEFT SH, .070", REF SA6ERADLSH. ... There is a potential for extensive loss of primary segment material exposing ... Class I
Mar 15, 2019 SHERPA NX ACTIVE GUIDING CATHETER, 6F, HSI, 100CM, 070", REF SA6HSI. for ca... There is a potential for extensive loss of primary segment material exposing ... Class I
Mar 15, 2019 SHERPA NX ACTIVE GUIDING CATHETER, 6F SAL3.0, .070", REF SA6SAL30. for card... There is a potential for extensive loss of primary segment material exposing ... Class I
Mar 15, 2019 SHERPA NX ACTIVE GUIDING CATHETER, 6F, AR2.0 SH, 100CM.070", REF SA6AR20SH. ... There is a potential for extensive loss of primary segment material exposing ... Class I
Mar 15, 2019 SHERPA NX ACTIVE GUIDING CATHETER, 6F JL4.0, .070", REF SA6JL40. for cardio... There is a potential for extensive loss of primary segment material exposing ... Class I
Mar 15, 2019 SHERPA NX ACTIVE GUIDING CATHETER, 6F ALR1-2, .070", REF SA6ALR12. for card... There is a potential for extensive loss of primary segment material exposing ... Class I
Mar 15, 2019 SHERPA NX ACTIVE GUIDING CATHETER, 6F AL2.5, .070:, REF SA6AL25. for cardio... There is a potential for extensive loss of primary segment material exposing ... Class I
Mar 15, 2019 SHERPA NX ACTIVE GUIDING CATHETER, 6F, AL.75 110CM.070", REF SA6AL75A. for ... There is a potential for extensive loss of primary segment material exposing ... Class I
Mar 15, 2019 SHERPA NX ACTIVE GUIDING CATHETER, 6F M RESS, .070", REF SA6MRESS. for card... There is a potential for extensive loss of primary segment material exposing ... Class I
Mar 15, 2019 SHERPA NX ACTIVE GUIDING CATHETER, 6F MP1 SH, .070", REF SA6MP1SH. for card... There is a potential for extensive loss of primary segment material exposing ... Class I
Mar 15, 2019 SHERPA NX ACTIVE GUIDING CATHETER, 6F JR3.5, .070", REF SA6JR35. for cardio... There is a potential for extensive loss of primary segment material exposing ... Class I
Mar 15, 2019 SHERPA NX ACTIVE GUIDING CATHETER, 6F SL3.5, .070", REF SA6SL35. for cardio... There is a potential for extensive loss of primary segment material exposing ... Class I
Mar 15, 2019 SHERPA NX ACTIVE GUIDING CATHETER, 6F RCB SH, .070", REF SA6RCBSH. for card... There is a potential for extensive loss of primary segment material exposing ... Class I
Mar 15, 2019 SHERPA NX ACTIVE GUIDING CATHETER, 6F, JR4.0, 55CM, 070", REF SA6JR40K. for... There is a potential for extensive loss of primary segment material exposing ... Class I
Mar 15, 2019 SHERPA NX ACTIVE GUIDING CATHETER, 6F CHAMP1.0, .070", REF SA6CHAMP10. for ... There is a potential for extensive loss of primary segment material exposing ... Class I
Mar 15, 2019 SHERPA NX ACTIVE GUIDING CATHETER, 6F EBU3.75 SH, .070", REF SA6EBU375SH. f... There is a potential for extensive loss of primary segment material exposing ... Class I
Mar 15, 2019 SHERPA NX ACTIVE GUIDING CATHETER, 6F HSII, .070", REF SA6HSII. for cardiov... There is a potential for extensive loss of primary segment material exposing ... Class I
Mar 15, 2019 SHERPA NX ACTIVE GUIDING CATHETER, 6F SCR4.0 SH, .070", REF SA6SCR40SH. for... There is a potential for extensive loss of primary segment material exposing ... Class I
Mar 15, 2019 SHERPA NX ACTIVE GUIDING CATHETER, 6F JL6.0, .070", REF SA6JL60. for cardi... There is a potential for extensive loss of primary segment material exposing ... Class I
Mar 15, 2019 SHERPA NX ACTIVE GUIDING CATHETER, 6F JR4.0, .070", REF SA6JR40. for cardio... There is a potential for extensive loss of primary segment material exposing ... Class I
Mar 15, 2019 SHERPA NX ACTIVE GUIDING CATHETER, 6F ECR4.0, .070", REF SA6ECR40. for card... There is a potential for extensive loss of primary segment material exposing ... Class I
Mar 15, 2019 SHERPA NX ACTIVE GUIDING CATHETER, 6F AL2.0, .070", REF SA6AL205. for cardi... There is a potential for extensive loss of primary segment material exposing ... Class I
Mar 15, 2019 SHERPA NX ACTIVE GUIDING CATHETER, 6F EBU3.75, .070", REF SA6EBU375. for ca... There is a potential for extensive loss of primary segment material exposing ... Class I
Mar 15, 2019 SHERPA NX ACTIVE GUIDING CATHETER, 6F, NOTO SH, 100CM, 070", REF SA6NOTOSH. ... There is a potential for extensive loss of primary segment material exposing ... Class I
Mar 15, 2019 SHERPA NX ACTIVE GUIDING CATHETER, 6F JR3.5 SH, .070", REF SA6JR35SH. for c... There is a potential for extensive loss of primary segment material exposing ... Class I
Mar 15, 2019 SHERPA NX ACTIVE GUIDING CATHETER, 6F MAC3.75 SH, .070", REF SA6MAC375SH. f... There is a potential for extensive loss of primary segment material exposing ... Class I
Mar 15, 2019 SHERPA NX ACTIVE GUIDING CATHETER, 6F FR4.0, .070", REF SA6FR40. for cardio... There is a potential for extensive loss of primary segment material exposing ... Class I
Mar 15, 2019 SHERPA NX ACTIVE GUIDING CATHETER, 6F JR4.5, .070", REF SA6JR45. for cardio... There is a potential for extensive loss of primary segment material exposing ... Class I
Mar 15, 2019 SHERPA NX ACTIVE GUIDING CATHETER, 6F EL GAMAL, .070", REF SA6ELGAMAL. for ... There is a potential for extensive loss of primary segment material exposing ... Class I
Mar 15, 2019 SHERPA NX ACTIVE GUIDING CATHETER, 6F, IMA, 100CM, 070", REF SA6IMA. for ca... There is a potential for extensive loss of primary segment material exposing ... Class I
Mar 15, 2019 SHERPA NX ACTIVE GUIDING CATHETER, 6F EBU4.0, .070", REF SA6EBU40. for card... There is a potential for extensive loss of primary segment material exposing ... Class I

View all 211 device recalls →

Frequently Asked Questions

A high number of recalls does not necessarily indicate that a company is unsafe. Large manufacturers that produce thousands of products across multiple categories will statistically appear in recall databases more frequently. What matters more is the severity of each recall (Class I being the most serious), the speed of response, and whether the company proactively identified and addressed the issue. Companies with robust safety programs often catch problems earlier.

Food, drug, and medical device recall data comes from the FDA's openFDA enforcement database, which contains all FDA enforcement reports. Consumer product recall data comes from the U.S. Consumer Product Safety Commission (CPSC). Both sources are public government databases that are updated regularly. RecallCheck aggregates these sources to provide a unified view of a company's recall history.

The FDA classifies recalls into three categories. Class I is the most serious — there is a reasonable probability that use of or exposure to the product will cause serious adverse health consequences or death. Class II means the product may cause temporary or medically reversible health problems, or the probability of serious consequences is remote. Class III is the least serious — the product is unlikely to cause adverse health consequences. CPSC product recalls do not use this classification system.

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