Instruments, Surgical, Cardiovascular
FDA adverse event reports and recall history for instruments, surgical, cardiovascular (product code DWS), from the public MAUDE/AEMS corpus and the live FDA recall database.
- Total reports
- 836
- Deaths
- 11
- Injuries
- 172
- Malfunctions
- 628
Reports per year
Source: FDA adverse event reports by year received, 2012–2026. Reporting paused during the 2026 MAUDE-to-AEMS transition and has since resumed.
Recent recalls
- 2025-05-07Open, ClassifiedProcess control
Introducer Needle REF NDL-107-04 These needles are used for the percutaneous introduction of guidewires
Due to a potential open seal in the sterile barrier packaging.
- 2023-09-01Open, ClassifiedUnder Investigation by firm
Cook Lead Clipper- An auxiliary tool indicated for use in patients requiring percutaneous retrieval of cardiac leads. Order Number (GPN): G20003 Reference Part Number (RPN): LR-CLP001
Sterility of device may be compromised due to breach of the chevron seal of the packaging
- 2023-07-31Open, ClassifiedNonconforming Material/Component
ACCESSRAIL Platform (Standard Blade) Part Number SB-1000, and (Deep Blades) Part Number C-DB-1000. Component of a chest stabilization system for cardiac and chest surgery.
The Standard Blade may not securely latch onto the Activator Drive. This may result in the inability to stabilize and position or may result in the loss of stabilization and positioning of heart, release of device component into the patient, and/or a procedural delay and/or conversion.
- 2023-07-31Open, ClassifiedNonconforming Material/Component
ACROBAT SUV Vacuum Off-Pump System, Part Number C-OM-9000S. Component of a chest stabilization system for cardiac and chest surgery.
The Standard Blade may not securely latch onto the Activator Drive. This may result in the inability to stabilize and position or may result in the loss of stabilization and positioning of heart, release of device component into the patient, and/or a procedural delay and/or conversion.
- 2023-07-31Open, ClassifiedNonconforming Material/Component
ACROBAT V Vacuum Off-Pump System, Part Number C-OM-9100S. Component of a chest stabilization system for cardiac and chest surgery.
The Standard Blade may not securely latch onto the Activator Drive. This may result in the inability to stabilize and position or may result in the loss of stabilization and positioning of heart, release of device component into the patient, and/or a procedural delay and/or conversion.
- 2023-07-31Open, ClassifiedNonconforming Material/Component
ACROBAT-i Vacuum Stabilizer System, Part Number C-OM-10000. Component of a chest stabilization system for cardiac and chest surgery.
The Standard Blade may not securely latch onto the Activator Drive. This may result in the inability to stabilize and position or may result in the loss of stabilization and positioning of heart, release of device component into the patient, and/or a procedural delay and/or conversion.
- 2020-02-19TerminatedPackaging
Teleflex Pilling Aortic Punch, 4.0mm. Sterile, Rx Only, disposable. Included as part of Intl-Cardiac Surgery Kit - Product Usage: This device is used for cardiovascular surgical procedures.
The sterile packaging has the potential to be compromised.
- 2020-01-27TerminatedUnder Investigation by firm
Pilling Aortic Punch, 4.0 mm Standard Tip, REF 353440
There is a potential for the device packaging to become compromised; thus, the sterility of the device cannot be guaranteed.
- 2020-01-27TerminatedUnder Investigation by firm
Teleflex Medical Disposable Aortic Punch, in the following sizes: a) 2.8 mm, REF DP-28K b) 3.6 mm, REF DP-36K c) 4.0 mm, REF DP-40K d) 4.4 mm, REF DP-44K e) 4.8 mm, REF DP-48K f) 5.2 mm, REF DP-52K g) 5.6 mm, REF DP-56K h) 6.0 mm, REF DP-60K i) 2.8 mm, REF MDP-28K j) 3.6 mm, REF MDP-36K k) 4.0 mm, REF MDP-40K l) 4.4 mm, REF MDP-44K m) 4.8 mm, REF MDP-48K n) 5.2 mm, REF MDP-52K o) 5.6 mm, REF MDP-56K p) 6.0 mm, REF MDP-60K
There is a potential for the device packaging to become compromised; thus, the sterility of the device cannot be guaranteed.
- 2016-11-22TerminatedMaterial/Component Contamination
The Hemotherm 400CE 115v, containing power board p/n 39945
The device may not maintain water flow or temperature control.
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