—#181538

Product

Arrow AC3 Optimus Intra-Aortic Balloon Pump AC3 Optimus IABP NA/AJLA, Product Code IAP-0701

FDA product code: DSP — System, Balloon, Intra-Aortic And Control
Device class: Class 2
Medical specialty: Cardiovascular
510(k) numbers: K162820
Affected lot / code info: 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

Why it was recalled

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.

Root cause (FDA determination)

Component design/selection

Action the firm took

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

Recalling firm

Firm: Arrow International Inc
Address: 2400 Bernville Rd, Reading, Pennsylvania 19605-9607

Distribution

Distribution pattern: Worldwide distribution.

Timeline

Recall initiated: 2020-05-20
Posted by FDA: 2020-06-26
Terminated: 2023-01-07
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #181538. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.