Arrow International Inc

Complete recall history across all FDA and CPSC categories — 431 total recalls

Arrow International Inc 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 (431)

FDA medical device enforcement actions by Arrow International Inc. Showing most recent 50.

Date Product Reason Class
Sep 20, 2021 Arrow-Trerotola Over-The-Wire PTD Kit Percutaneous Thrombolytic Device : 7FR ... 7FR Percutaneous Thrombolytic Device (PTD) Inner lumen (orange) detached from... Class I
Sep 20, 2021 Arrow-Trerotola Over-The-Wire PTD Kit Percutaneous Thrombolytic Device : 7FR ... 7FR Percutaneous Thrombolytic Device (PTD) Inner lumen (orange) detached from... Class I
Sep 20, 2021 Arrow-Trerotola Over-The-Wire PTD Kit Percutaneous Thrombolytic Device : 7FR ... 7FR Percutaneous Thrombolytic Device (PTD) Inner lumen (orange) detached from... Class I
Sep 20, 2021 Arrow-Trerotola Over-The-Wire PTD Kit Percutaneous Thrombolytic Device : 7FR ... 7FR Percutaneous Thrombolytic Device (PTD) Inner lumen (orange) detached from... Class I
May 19, 2021 Arrow Temporary Pacing Catheter/Introducer Kit 5Fr. pacing catheter 6 Fr. int... Marketed without a 510K Class II
May 19, 2021 Arrow Bipolar Balloon Electrode Catheter 5 Fr. 105 cm, Product Code: AI-0715... Marketed without a 510K Class II
May 19, 2021 Arrow Temporary Pacing Catheter/Introducer Kit 6Fr. pacing catheter 7Fr. intr... Marketed without a 510K Class II
May 19, 2021 Arrow Pacing Catheter Kit-Bipolar Electrode Catheter 5 Fr. 110 cm, Product Co... Marketed without a 510K Class II
Mar 8, 2021 Arrow OnControl Bone Lesion Biopsy System Tray-11 ga 10 cm Access/13 ga 14 cm... Difficulty inserting the biopsy ejector rod into the bone lesion biopsy cannu... Class II
Jan 6, 2021 Arrow AGB+ Multi-Lumen CVC Kit 7Fr 3 Lumen- Intended for venous access to the... The lidstock / information card on the kits correctly states the product code... Class II
Jul 6, 2020 Arrow TheraCath Epidural Catheter - Product Usage: The Arrow Epidural Cathete... The lidstock states the incorrect expiration date for the product. This issue... Class II
Jul 6, 2020 Arrow Single Shot Epidural Anesthesia Kit - Product Usage: The Arrow Blunt Ne... The lidstock states the incorrect expiration date for the product. This issue... Class II
Jul 6, 2020 NextStep Retrograde Replacement Hub Set - Product Usage: is indicated for use... The lidstock states the incorrect expiration date for the product. This issue... Class II
Jul 6, 2020 Cannon II Plus Replacement Hub Set - Product Usage: is indicated for use in t... The lidstock states the incorrect expiration date for the product. This issue... Class II
May 20, 2020 Arrow AutoCAT2 Intra-Aortic Balloon Pump AUTOCAT2 SPANISH, Product Code IAP-0... A potential issue with a component within the above-referenced IABPs may impa... Class I
May 20, 2020 Arrow AutoCAT2 Intra-Aortic Balloon Pump AUTOCAT2 WAVE SPANISH, Product Code ... A potential issue with a component within the above-referenced IABPs may impa... Class I
May 20, 2020 Arrow AutoCAT2 Intra-Aortic Balloon Pump AEROAUTOCAT 2 WAVE, Product Code IAP... A potential issue with a component within the above-referenced IABPs may impa... Class I
May 20, 2020 Arrow AC3 Optimus Intra-Aortic Balloon Pump AC3 Optimus IABP NA/EMEA, Product... A potential issue with a component within the above-referenced IABPs may impa... Class I
May 20, 2020 Arrow AutoCAT2 Intra-Aortic Balloon Pump AUTOCAT2 WAVE ITALIAN, Product Code ... A potential issue with a component within the above-referenced IABPs may impa... Class I
May 20, 2020 Arrow AutoCAT2 Intra-Aortic Balloon Pump AUTOCAT2 WAVE DUTCH, Product Code IA... A potential issue with a component within the above-referenced IABPs may impa... Class I
May 20, 2020 Arrow AutoCAT2 Intra-Aortic Balloon Pump AUTOCAT 2, Product Code IAP-0400 A potential issue with a component within the above-referenced IABPs may impa... Class I
May 20, 2020 Arrow AutoCAT2 Intra-Aortic Balloon Pump AUTOCAT2 WAVE JAPANESE, Product Code... A potential issue with a component within the above-referenced IABPs may impa... Class I
May 20, 2020 Arrow AC3 Optimus Intra-Aortic Balloon Pump AC3 Optimus IABP NA/AJLA, Product... A potential issue with a component within the above-referenced IABPs may impa... Class I
May 20, 2020 Arrow AutoCAT2 Intra-Aortic Balloon Pump AUTOCAT2 WAVE, Product Code IAP-0500 A potential issue with a component within the above-referenced IABPs may impa... Class I
May 8, 2020 Arrow FlexTip Plus Epidural Kit with NRFit Connector, catheter system, Produc... Nine complaints reported that the rotatable collar on the filter had detached... Class II
Jan 15, 2020 FlexTip Plus Epidural Catheterization Kit, Product Code TI-05501-ME There is the potential for various failures with the LOR (loss of resistance)... Class II
Jan 15, 2020 FlexTip Plus Epidural Catheterization Kit, Product Code YC-02220 There is the potential for various failures with the LOR (loss of resistance)... Class II
Jan 15, 2020 EPIDURAL CATHETERIZATION KIT, Product Code MTO-09903-KU There is the potential for various failures with the LOR (loss of resistance)... Class II
Jan 15, 2020 FlexTip Plus Epidural Catheterization Kit, Product Code ASK-05503-BID There is the potential for various failures with the LOR (loss of resistance)... Class II
Jan 15, 2020 FlexTip Plus Epidural Catheterization Kit, Product Code AK-05501 There is the potential for various failures with the LOR (loss of resistance)... Class II
Jan 15, 2020 EPIDURAL CATHETERIZATION KIT, Product Code FR-05501-04 There is the potential for various failures with the LOR (loss of resistance)... Class II
Jan 15, 2020 FlexTip Plus Epidural Catheterization Kit, Product Code JC-05400-E There is the potential for various failures with the LOR (loss of resistance)... Class II
Jan 15, 2020 FlexTip Plus Combined Spinal Epidural Catheterization Kit, Product Code ASK-0... There is the potential for various failures with the LOR (loss of resistance)... Class II
Jan 15, 2020 EPIDURAL CATHETERIZATION KIT, Product Code BE-05400-DCHH There is the potential for various failures with the LOR (loss of resistance)... Class II
Jan 15, 2020 FlexTip Plus Epidural Catheterization Set, Product Code JC-05400-B There is the potential for various failures with the LOR (loss of resistance)... Class II
Jan 15, 2020 FlexTip Plus Combined Spinal Epidural Catheterization Kit, Product Code NYU-0... There is the potential for various failures with the LOR (loss of resistance)... Class II
Jan 15, 2020 EPIDURAL CATHETERIZATION KIT, Product Code CZ-05400-EPI There is the potential for various failures with the LOR (loss of resistance)... Class II
Jan 15, 2020 EPIDURAL CATHETERIZATION KIT, Product Code BE-080180-BXL There is the potential for various failures with the LOR (loss of resistance)... Class II
Jan 15, 2020 FlexTip Plus Combined Spinal Epidural Catheterization Set, Product Code AA-05... There is the potential for various failures with the LOR (loss of resistance)... Class II
Jan 15, 2020 FlexTip Plus Epidural Catheterization Kit, Product Code MP-17019-TKP There is the potential for various failures with the LOR (loss of resistance)... Class II
Jan 15, 2020 EPIDURAL CATHETERIZATION KIT, Product Code BE-05400-DCSHO There is the potential for various failures with the LOR (loss of resistance)... Class II
Jan 15, 2020 FlexTip Plus Combined Spinal Epidural Catheterization Kit, Product Code ASK-0... There is the potential for various failures with the LOR (loss of resistance)... Class II
Jan 15, 2020 FlexTip Plus Epidural Catheterization Kit, Product Code ASK-05501-SH There is the potential for various failures with the LOR (loss of resistance)... Class II
Jan 15, 2020 Epidural Catheterization Kit with FlexTip Plus Catheter, Product Code TI-0552... There is the potential for various failures with the LOR (loss of resistance)... Class II
Jan 15, 2020 EPIDURAL CATHETERIZATION KIT, Product Code AT-05501-LIN There is the potential for various failures with the LOR (loss of resistance)... Class II
Jan 15, 2020 FlexTip Plus Combined Spinal Epidural Catheterization Kit, Product Code ASK-0... There is the potential for various failures with the LOR (loss of resistance)... Class II
Jan 15, 2020 FlexTip Plus Epidural Catheterization Set, Product Code MTO-05500-TK There is the potential for various failures with the LOR (loss of resistance)... Class II
Jan 15, 2020 EPIDURAL CATHETERIZATION KIT, Product Code FR-05501-10 There is the potential for various failures with the LOR (loss of resistance)... Class II
Jan 15, 2020 FlexTip Plus Epidural Catheterization Kit, Product Code AK-05500 There is the potential for various failures with the LOR (loss of resistance)... Class II
Jan 15, 2020 EPIDURAL CATHETERIZATION KIT, Product Code MTO-05500-SU There is the potential for various failures with the LOR (loss of resistance)... Class II

View all 431 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.

Yes. You can search for any company using the firm/manufacturer pages for each category: Food Firms, Drug Firms, Device Firms, or Product Manufacturers. You can also use the search functionality on any browse page to find recalls by company name.

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