Arrow AutoCAT 2 & AC3 Optimus Intra-Aortic Balloon Pump (2020-05-22)
- Starting date:
- May 22, 2020
- Posting date:
- June 12, 2020
- Type of communication:
- Medical Device Recall
- Subcategory:
- Medical Device
- Hazard classification:
- Type II
- Source of recall:
- Health Canada
- Issue:
- Medical Devices
- Audience:
- General Public, Healthcare Professionals, Hospitals
- Identification number:
- RA-73315
Last updated: 2020-06-12
Affected Products
- Arrow AutoCAT 2 Intra-Aortic Balloon Pump
- Arrow AC3 Optimus Intra-Aortic Balloon Pump
Reason
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.
Affected products
A. Arrow AutoCAT 2 Intra-Aortic Balloon Pump
Lot or serial number
More than 10 numbers, contact manufacturer.
Model or catalog number
IAP-0500
Companies
- Manufacturer
-
Arrow International, Inc. (Subsidiary of Teleflex, Incorporated)
2400 Bernville Road
Reading
19605
Pennsylvania
UNITED STATES
B. Arrow AC3 Optimus Intra-Aortic Balloon Pump
Lot or serial number
More than 10 numbers, contact manufacturer.
Model or catalog number
IAP-0700
Companies
- Manufacturer
-
Arrow International, Inc. (Subsidiary of Teleflex, Incorporated)
2400 Bernville Road
Reading
19605
Pennsylvania
UNITED STATES