Arrow AC3 Optimus Intra-Aortic Balloon Pump AC3 Optimus IABP NA/EMEA, Product Code IAP-0700
Class I - DangerousWhat Should You Do?
- Check if you have this product: Serial Number Ranges: Arrow AC3 Optimus Intra-Aortic Balloon Pump AC3 Optimus IABP NA/EMEA IAP-0700 150312F through 150313F 150315F 150318F 150321F 150324F through 150326F 161101F through 161110F 161112F through 161120F 161201F through 161210F 170101F through 170120F 170701F through 170710F 170801F through 170810F 170901F through 170920F 170931F through 170940F 171002F through 171010F 171031F through 171036F 171126F through 171130F 180101F through 180105F Arrow AC3 Optimus Intra-Aortic Balloon Pump AC3 Optimus IABP NA/EMEA IAP-0700 180121F through 180125F 180201F through 180210F 180311F through 180330F 180401F through 180410F 180421F through 180425F 180431F through 180440F 180511F through 180520F 180601F through 180605F 180701F through 180710F 180801F through 180810F 180821F through 180825F 180922F through 180931F 181041F through 181050F 181101F through 181110F 181201F through 181210F 190101F through 190110F 190131F through 190135F 190201F through 190210F 190231F through 190250F 190301F through 190303F 190305F through 190320F 190331F through 190335F 190401F through 190410F 190421F through 190430F 190441F through 190450F 190501F through 190510F 190541F through 190550F 190601F through 190620F 190641F through 190645F 190713F through 190730F 190801F through 190812F 190826F through 190834F 190901F through 190912F 190925F through 190930F 191013F through 191018F 191037F through 191042F 191049F through 191054F 191113F through 191136F 191201F through 191212F 200101F through 200106F 200137F through 200148F 200201F through 200212F Arrow AC3 Optimus Intra-Aortic Balloon Pump AC3 Optimus IABP NA/EMEA IAP-0700 200301F through 200306F 200325F through 200326F 200328F through 200339F 200341F through 200348F
- 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/EMEA, Product Code IAP-0700
Product Codes/Lot Numbers:
Serial Number Ranges: Arrow AC3 Optimus Intra-Aortic Balloon Pump AC3 Optimus IABP NA/EMEA IAP-0700 150312F through 150313F 150315F 150318F 150321F 150324F through 150326F 161101F through 161110F 161112F through 161120F 161201F through 161210F 170101F through 170120F 170701F through 170710F 170801F through 170810F 170901F through 170920F 170931F through 170940F 171002F through 171010F 171031F through 171036F 171126F through 171130F 180101F through 180105F Arrow AC3 Optimus Intra-Aortic Balloon Pump AC3 Optimus IABP NA/EMEA IAP-0700 180121F through 180125F 180201F through 180210F 180311F through 180330F 180401F through 180410F 180421F through 180425F 180431F through 180440F 180511F through 180520F 180601F through 180605F 180701F through 180710F 180801F through 180810F 180821F through 180825F 180922F through 180931F 181041F through 181050F 181101F through 181110F 181201F through 181210F 190101F through 190110F 190131F through 190135F 190201F through 190210F 190231F through 190250F 190301F through 190303F 190305F through 190320F 190331F through 190335F 190401F through 190410F 190421F through 190430F 190441F through 190450F 190501F through 190510F 190541F through 190550F 190601F through 190620F 190641F through 190645F 190713F through 190730F 190801F through 190812F 190826F through 190834F 190901F through 190912F 190925F through 190930F 191013F through 191018F 191037F through 191042F 191049F through 191054F 191113F through 191136F 191201F through 191212F 200101F through 200106F 200137F through 200148F 200201F through 200212F Arrow AC3 Optimus Intra-Aortic Balloon Pump AC3 Optimus IABP NA/EMEA IAP-0700 200301F through 200306F 200325F through 200326F 200328F through 200339F 200341F through 200348F
Official Source
Always verify recall information with the official FDA source:
View on FDA.govFDA Recall Number: Z-2416-2020
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.