Arrow AutoCAT2 Intra-Aortic Balloon Pump AUTOCAT2 WAVE JAPANESE, Product Code IAP-0500J
- Company
- Arrow International Inc
- Recall Initiated
- May 20, 2020
- Posted
- June 26, 2020
- Terminated
- January 7, 2023
- Recall Number
- Z-2413-2020
- Quantity
- 2123 total
- Firm Location
- Reading, PA
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.
Distribution
Worldwide distribution.
Lot / Code Info
Serial Number Ranges: AUTOCAT2 WAVE JAPANESE IAP-0500J 140866W through 140867W 150117W through 150118W 150120W 150201W 150305W 150307W through 150309W 150623W through 150624W 150713W through 150716W 151114W 151209W 151213W 151219W 160503W 160511W through 160515W 160517W 160635W through 160636W 160640W through 160641W 160731W through 160733W 171105W 171117W 171119W through 171120W 171201W 180120W 180301W
Root Cause
Component design/selection
Action Taken
Urgent Medical Device Correction notification letters dated 5/20/20 were sent to customers. ACTIONS TO BE TAKEN BY FACILITIES (Immediate): Please immediately check your inventory of Arrow AutoCAT2 and Arrow AC3 Optimus IABPs, whether stored or in use, and determine if you have an IABP with a model number listed above. Please see Appendix 1 for product codes and serial numbers. If an IABP in the scope of this Medical Device Correction displays a System Error 3 or High Baseline alarm, now or at any point in the future until the Long-Term Corrective Action detailed below occurs, immediately quarantine the device and contact Teleflex at 1-855-419-8507 or recalls@teleflex.com to receive support for inspection and servicing of the impacted device. We recommend against using an IABP for ground or air transport between medical facilities pending implementation of the Customer Action (Long Term). For IABP use during ground or air transport prior to implementation of the Customer Action (Long Term), it is recommended that the risks and benefits of using the IABP be assessed by the medical team treating the patient and that alternative circulatory support devices be considered. Customer Action (Subsequent): Teleflex will contact each impacted facility to schedule inspection and servicing of all IABP units that contain this internal component. This inspection and servicing will be performed onsite at facilities, for all IABP units. Facilities should adhere to the following instructions pending implementation of the Teleflex Long-Term Corrective Action described later in this letter: 1. Ensure that a backup IABP is available as instructed within the Operator Manual. If no such replacement IABP is immediately available, it is recommended that the risks and benefits of using the IABP be assessed by the medical team treating the patient and that alternative circulatory support devices be considered. 2. IABP units should be closely monitored during delivery of IAB