Arrow AC3 Optimus Intra-Aortic Balloon Pump AC3 Optimus IABP NA/AJLA, Product Code IAP-0701
Class I - DangerousWhat Should You Do?
- Check if you have this product: Serial Number Ranges: AC3 Optimus IABP NA/AJLA IAP-0701 170831F through 170840F 171011F through 171020F 171121F through 171125F 180106F through 180110F 180126F through 180130F 180426F through 180430F 180606F through 180610F 180731F through 180740F 180826F through 180830F 180901F through 180910F 180912F through 180921F 181001F through 181010F 190136F through 190140F 190336F through 190340F 190646F through 190650F 190731F through 190736F 190931F through 190936F 191019F through 191024F 191055F through 191060F 200107F through 200112F 200308F through 200311F
- Do not eat it: Even if it looks and smells fine, do not consume this product.
- Throw it away or return it: You can return the product to the store for a full refund.
- Seek medical attention if needed: If you've consumed this product and feel unwell, contact your doctor immediately.
- Report problems: Report any issues to the FDA's Safety Reporting Portal.
⚠️ Emergency: If you experience severe symptoms after consuming this product, call 911 or Poison Control at 1-800-222-1222.
Recall Details
- Company:
- Arrow International Inc
- Reason for Recall:
- A potential issue with a component within the above-referenced IABPs may impact the ability of the devices to operate. A Component within the IABP is susceptible to vibration failure resulting in fretting, charring, and discoloration of motor connector wires, which may result in pump alarms for System Error 3 and High Baseline presented on the screen of the IABP, and potential abrupt cessation of function or inability to start the IABP.
- Classification:
- Class I - Dangerous
Dangerous or defective products that predictably could cause serious health problems or death.
- Status:
- terminated
Product Information
Full Description:
Arrow AC3 Optimus Intra-Aortic Balloon Pump AC3 Optimus IABP NA/AJLA, Product Code IAP-0701
Product Codes/Lot Numbers:
Serial Number Ranges: AC3 Optimus IABP NA/AJLA IAP-0701 170831F through 170840F 171011F through 171020F 171121F through 171125F 180106F through 180110F 180126F through 180130F 180426F through 180430F 180606F through 180610F 180731F through 180740F 180826F through 180830F 180901F through 180910F 180912F through 180921F 181001F through 181010F 190136F through 190140F 190336F through 190340F 190646F through 190650F 190731F through 190736F 190931F through 190936F 191019F through 191024F 191055F through 191060F 200107F through 200112F 200308F through 200311F
Official Source
Always verify recall information with the official FDA source:
View on FDA.govFDA Recall Number: Z-2417-2020
Related Recalls
Reports have been received regarding open seals on the packaging.
Arrow FiberOptix Intra-Aortic Balloon Catheter Kit: a) REF IAB-05830-LWS; b) REF IAB-05840-LWS; c) REF IAB-05850-LWS
ARROW INTERNATIONAL
Teleflex received reports indicating an infrequent condition that, when not identified and corrected promptly, could result in serious health consequences. The issue may manifest as: -failure of the intra-aortic balloon to completely inflate over its full length -damaged or broken central lumen in the segment contained within the balloon -helium loss or blood in the helium pathway.
Arrow UltraFlex Intra-Aortic Balloon Catheter Kit, a) REF IAB-06830-U; b) REF IAB-06840-U; c) REF IAB-06850-U
ARROW INTERNATIONAL
Teleflex received reports indicating an infrequent condition that, when not identified and corrected promptly, could result in serious health consequences. The issue may manifest as: -failure of the intra-aortic balloon to completely inflate over its full length -damaged or broken central lumen in the segment contained within the balloon -helium loss or blood in the helium pathway.