| Date Initiated by Firm |
May 20, 2020 |
| Date Posted |
June 26, 2020 |
| Recall Status1 |
Terminated 3 on January 07, 2023 |
| Recall Number |
Z-2408-2020 |
| Recall Event ID |
85684 |
| 510(K)Number |
K060309
|
| Product Classification |
System, balloon, intra-aortic and control - Product Code DSP
|
| Product |
Arrow AutoCAT2 Intra-Aortic Balloon Pump AUTOCAT 2, Product Code IAP-0400 |
| Code Information |
Serial number ranges: Arrow AutoCAT 2 Intra-Aortic Balloon Pump AUTOCAT 2 IAP-0400 140868V 140901V through 140909V 140914V through 140920V 150102V 150106V through 150107V 150110V through 150113V 150115V through 150116V 150220V 150401V 150407V 150409V 150507V through 150513V 150601V through 150605V 150608V through 150611V 150625V 150702V through 150705V 150707V 150720V 150801V through 150802V 150821V 150824V 150827V through 150830V 150901V through 150906V 150908V through 150912V 150919V through 150923V 150925V through 150939V 151009V through 151013V 151015V through 151016V 151019V 151021V through 151027V 151029V 151102V through 151103V 151105V 151108V 151111V 151113V 151201V through 151208V 151210V through 151212V 151214V through 151218V Arrow AutoCAT 2 Intra-Aortic Balloon Pump AUTOCAT 2 IAP-0400 151220V 160101V through 160103V 160105V through 160109V 160112V through 160118V 160120V 160122V 160126V 160201V through 160209V 160211V 160213V through 160214V 160216V through 160217V 160219V 160312V through 160314V 160316V through 160323V 160325V through 160327V 160331V 160401V through 160410V 160412V 160418V through 160422V 160519V 160525V 160529V through 160530V 160605V 160614V 160618V 160630V 160638V through 160639V 160645V 160703V 160718V 160720V 160726V 160728V through 160730V 170101V through 170110V 170401V through 170410V 170501V through 170520V 170601V through 170625V 170811V through 170830V 171021V through 171030V 171037V through 171046V 171106V through 171115V 180131V through 180150V Arrow AutoCAT 2 Intra-Aortic Balloon Pump AUTOCAT 2 IAP-0400 180211V through 180230V 180411V through 180420V 180441V through 180450V 180521V through 180530V 180621V through 180630V 180711V through 180720V 180741V through 180750V 180811V through 180820V 181011V through 181040V 181111V through 181130V 190121V through 190130V 190141V through 190150V 190211V through 190220V 190411V through 190420V 190431V through 190440V 190531V through 190540V 190701V through 190712V 190737V through 190748V 190813V through 190824V 190837V through 190848V 190913V through 190924V 190937V through 190948V 191001V through 191012V 191025V through 191036V 191101V through 191112V 191137V through 191148V 200113V through 200136V 200314V through 200324V |
Recalling Firm/
Manufacturer |
Arrow International Inc
2400 Bernville Rd
Reading PA 19605-9607
|
| For Additional Information Contact |
610-378-0131
|
Manufacturer 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.
|
FDA Determined
Cause 2 |
Component design/selection |
| Action |
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¿ AutoCAT¿2 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 |
| Quantity in Commerce |
2123 total |
| Distribution |
Worldwide distribution. |
| Total Product Life Cycle |
TPLC Device Report
|
|
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
|
| 510(K) Database |
510(K)s with Product Code = DSP and Original Applicant = ARROW INTL., INC.
|
