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U.S. Department of Health and Human Services

Class 1 Device Recall Arrow AutoCAT2

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  Class 1 Device Recall Arrow AutoCAT2 see related information
Date Initiated by Firm May 20, 2020
Date Posted June 26, 2020
Recall Status1 Terminated 3 on January 07, 2023
Recall Number Z-2410-2020
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 AUTOCAT2 WAVE, Product Code IAP-0500
Code Information 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 
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.
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