Arrow AutoCAT2 Intra-Aortic Balloon Pump AUTOCAT2 WAVE, Product Code IAP-0500
Class I - DangerousWhat Should You Do?
- Check if you have this product: Serial Number Ranges: AUTOCAT2 WAVE IAP-0500 140861W through 140865W 140910W through 140913W 150101W 150103W through 150105W 150108W through 150109W 150114W 150119W 150202W through 150219W 150303W Arrow AutoCAT 2 Intra-Aortic Balloon Pump AUTOCAT2 WAVE IAP-0500 150306W 150310W 150404W through 150406W 150410W 150501W through 150506W 150515W 150606W through 150607W 150612W through 150622W 150701W 150706W 150708W through 150712W 150717W through 150719W 150803W through 150820W 150822W through 150823W 150825W 150913W through 150918W 150924W 150940W 151001W through 151008W 151017W through 151018W 151020W 151028W 151109W 151112W 151115W through 151120W 160104W 160110W through 160111W 160121W 160123W through 160125W 160127W through 160130W 160210W 160212W 160215W 160218W 160220W 160301W through 160304W 160307W through 160311W 160315W 160324W 160328W through 160330W 160332W through 160340W 160411W Arrow AutoCAT 2 Intra-Aortic Balloon Pump AUTOCAT2 WAVE IAP-0500 160413W through 160417W 160423W through 160424W 160428W 160501W through 160502W 160504W through 160507W 160520W through 160524W 160526W through 160528W 160601W through 160604W 160606W through 160613W 160615W through 160617W 160620W through 160629W 160632W through 160633W 160701W through 160702W 160704W 160706W through 160713W 160716W through 160717W 160719W 160721W through 160725W 160727W 160734W through 160742W 160744W through 160745W 160801W through 160803W 160805W through 160823W 160825W through 160827W 160829W through 160830W 160901W through 160917W 160920W through 160945W 170201W through 170203W 170207W through 170208W 170211W through 170220W 170222W through 170230W 170301W 170303W through 170307W 170309W through 170327W 170329W through 170330W 170606W through 170610W 170921W through 170927W 170929W through 170930W 170941W through 170950W 171101W through 171104W 171118W 171202W through 171205W Arrow AutoCAT 2 Intra-Aortic Balloon Pump AUTOCAT2 WAVE IAP-0500 180111W through 180119W 180302W through 180308W 180310W 180331W through 180332W 180334W through 180340W 180501W through 180510W 180531W through 180540W 180611W through 180620W 180721W through 180730W 180751W through 180760W 180831W through 180839W 180932W through 180938W 180940W through 180941W 181051W through 181053W 181055W 190111W through 190118W 190222W 190227W through 190228W 190230W 190321W through 190330W 190511W 190513W 190515W through 190518W 190520W through 190530W 190621W through 190630W 190634W through 190640W 190849W through 190860W 191043W through 191046W 191048W 200213W through 200236W
- 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 AutoCAT2 Intra-Aortic Balloon Pump AUTOCAT2 WAVE, Product Code IAP-0500
Product Codes/Lot Numbers:
Serial Number Ranges: AUTOCAT2 WAVE IAP-0500 140861W through 140865W 140910W through 140913W 150101W 150103W through 150105W 150108W through 150109W 150114W 150119W 150202W through 150219W 150303W Arrow AutoCAT 2 Intra-Aortic Balloon Pump AUTOCAT2 WAVE IAP-0500 150306W 150310W 150404W through 150406W 150410W 150501W through 150506W 150515W 150606W through 150607W 150612W through 150622W 150701W 150706W 150708W through 150712W 150717W through 150719W 150803W through 150820W 150822W through 150823W 150825W 150913W through 150918W 150924W 150940W 151001W through 151008W 151017W through 151018W 151020W 151028W 151109W 151112W 151115W through 151120W 160104W 160110W through 160111W 160121W 160123W through 160125W 160127W through 160130W 160210W 160212W 160215W 160218W 160220W 160301W through 160304W 160307W through 160311W 160315W 160324W 160328W through 160330W 160332W through 160340W 160411W Arrow AutoCAT 2 Intra-Aortic Balloon Pump AUTOCAT2 WAVE IAP-0500 160413W through 160417W 160423W through 160424W 160428W 160501W through 160502W 160504W through 160507W 160520W through 160524W 160526W through 160528W 160601W through 160604W 160606W through 160613W 160615W through 160617W 160620W through 160629W 160632W through 160633W 160701W through 160702W 160704W 160706W through 160713W 160716W through 160717W 160719W 160721W through 160725W 160727W 160734W through 160742W 160744W through 160745W 160801W through 160803W 160805W through 160823W 160825W through 160827W 160829W through 160830W 160901W through 160917W 160920W through 160945W 170201W through 170203W 170207W through 170208W 170211W through 170220W 170222W through 170230W 170301W 170303W through 170307W 170309W through 170327W 170329W through 170330W 170606W through 170610W 170921W through 170927W 170929W through 170930W 170941W through 170950W 171101W through 171104W 171118W 171202W through 171205W Arrow AutoCAT 2 Intra-Aortic Balloon Pump AUTOCAT2 WAVE IAP-0500 180111W through 180119W 180302W through 180308W 180310W 180331W through 180332W 180334W through 180340W 180501W through 180510W 180531W through 180540W 180611W through 180620W 180721W through 180730W 180751W through 180760W 180831W through 180839W 180932W through 180938W 180940W through 180941W 181051W through 181053W 181055W 190111W through 190118W 190222W 190227W through 190228W 190230W 190321W through 190330W 190511W 190513W 190515W through 190518W 190520W through 190530W 190621W through 190630W 190634W through 190640W 190849W through 190860W 191043W through 191046W 191048W 200213W through 200236W
Official Source
Always verify recall information with the official FDA source:
View on FDA.govFDA Recall Number: Z-2410-2020
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.