Medtronic Neurosurgery

Complete recall history across all FDA and CPSC categories — 31 total recalls

Medtronic Neurosurgery 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 (31)

FDA medical device enforcement actions by Medtronic Neurosurgery

Date Product Reason Class
Nov 1, 2024 Becker External Drainage and Monitoring System: 24146 EDMS 24146 BECKER NO Y... Due to complaints received reporting cracks and/or leaks of the stopcocks ass... Class I
Nov 1, 2024 Exacta External Drainage and Monitoring System: 27581 KIT 27581 EXACTA W/EDM... Due to complaints received reporting cracks and/or leaks of the stopcocks ass... Class I
Jan 22, 2024 Medtronic Duet External Drainage and Monitoring System, Interlink Injection S... Potential for catheter disconnection from the patient line stopcock connect... Class I
Jan 22, 2024 Medtronic Duet External Drainage and Monitoring System, SmartSite Injection S... Potential for catheter disconnection from the patient line stopcock connect... Class I
Jan 22, 2024 Medtronic Duet External Drainage and Monitoring System, Interlink Injection S... Potential for catheter disconnection from the patient line stopcock connect... Class I
Jan 22, 2024 Medtronic Duet External Drainage and Monitoring System, SmartSite, Injection ... Potential for catheter disconnection from the patient line stopcock connect... Class I
Jan 22, 2024 Medtronic Duet External Drainage and Monitoring System, Interlink Injection S... Potential for catheter disconnection from the patient line stopcock connect... Class I
Jun 28, 2023 Medtronic REF 46915 Duet External Drainage and Monitoring system, Interlink I... Product labeling contains incorrect expiration date Class II
Jun 13, 2023 Durepair Dura Regeneration Matrix: DUREPAIR DURA SUBSTITUTE 2 X 2, 61100; ... Dura regeneration matrix may have out-of-specification endotoxin levels due t... Class II
Jan 11, 2021 Medtronic Delta CSF (Cerebro Spinal Fluid) -Flow Control Valves for the foll... Potential for variation in radiopaque marking visibility under radiographic i... Class II
Jan 11, 2021 Medtronic PS Medical Cerebro Spinal Fluid (CSF)-Flow Control Valves for the... Potential for variation in radiopaque marking visibility under radiographic i... Class II
Jan 11, 2021 Medtronic Cerebro Spinal Fluid Flow Control Valves and Shunts. STRATA II V... Potential for variation in radiopaque marking visibility under radiographic i... Class II
Dec 16, 2020 REF 27219-1 X1, Medtronic, Delta Valve, Neonatal, Performance Level 1.0, CE ... Neonatal Valves were manufactured with a ventricular catheter connection site... Class II
Dec 16, 2020 REF 27219-5 X1, Medtronic, Delta Valve, Neonatal, Performance Level 1.5, CE ... Neonatal Valves were manufactured with a ventricular catheter connection site... Class II
Dec 16, 2020 REF 27219-2 X1, Medtronic, Delta Valve, Neonatal, Performance Level 2.0, CE ... Neonatal Valves were manufactured with a ventricular catheter connection site... Class II
Dec 8, 2020 Medtronic Ares Antibiotic-Impregnated Catheter, REF: 93092, Sterile, Rx Only.... There is a potential for a defect on the seal of the outer pouch of catheters... Class II
Dec 8, 2020 Medtronic Ares Antibiotic-Impregnated Catheter, REF: 91101, Sterile, Rx Only.... There is a potential for a defect on the seal of the outer pouch of catheters... Class II
Dec 8, 2020 Medtronic Ares Antibiotic-Impregnated Catheter, REF: 95001, Sterile, Rx Only.... There is a potential for a defect on the seal of the outer pouch of catheters... Class II
May 3, 2018 Medtronic Clip Gun Magazines are packaged in individually sealed pouches and ... The packaging sterile barrier does not comply with the applicable packaging s... Class II
Dec 20, 2017 Model #: CG8900, Medtronic Clip Gun Scalp Clip Kit (Qty 1); Model #: CG8901, ... Medtronic is initiating a voluntary recall because the products identified ab... Class II
Feb 22, 2017 The Medtronic StrataMR adjustable valves and shunts are designed to provide c... Incorrect valve rotor orientation due to misalignment and/or off-center posit... Class I
Jan 17, 2017 Medtronic Strata II / Strata NSC Valves (includes Burr Hole and Lumbar Perito... Medtronic Neurosurgery initiated a recall after receiving five (5) Product Ex... Class II
Jun 9, 2014 Medtronic Duet External Drainage and Monitoring System, Interlink Injection S... Medtronic Neurosurgery is recalling the Medtronic Duet External Drainage and ... Class I
Jun 9, 2014 Medtronic Duet External Drainage and Monitoring System, SmartSite Injection S... Medtronic Neurosurgery is recalling the Medtronic Duet External Drainage and ... Class I
Jun 9, 2014 Medtronic Duet External Drainage and Monitoring System, Interlink Injection S... Medtronic Neurosurgery is recalling the Medtronic Duet External Drainage and ... Class I
Jun 9, 2014 Medtronic Duet External Drainage and Monitoring System, Interlink Injection S... Medtronic Neurosurgery is recalling the Medtronic Duet External Drainage and ... Class I
Jun 9, 2014 Medtronic Duet External Drainage and Monitoring System, SmartSite Injection S... Medtronic Neurosurgery is recalling the Medtronic Duet External Drainage and ... Class I
Nov 18, 2013 CSF-Unitized Shunt, Contoured Regular, Low Pressure, Catalog No. 46022; CSF-... Medtronic Neurosurgery is recalling the CSF-Unitized Shunts, Delta Shunt Asse... Class II
Nov 18, 2013 Medtronic Strata II Shunt Assembly Kit, Small, Catalog No. 27848. Strata ... Medtronic Neurosurgery is recalling the CSF-Unitized Shunts, Delta Shunt Asse... Class II
Nov 18, 2013 Medtronic Delta Shunt Assembly Kit with Bioglide Small, Performance Level 1.0... Medtronic Neurosurgery is recalling the CSF-Unitized Shunts, Delta Shunt Asse... Class II
Jun 28, 2013 Medtronic Preimplantation Test Kit, Catalog No. 21047. The kit is indicated f... Medtronic Neurosurgery is recalling the Medtronic Preimplantation Test Kit be... Class II

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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