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On 02-Jul-2020, US-FDA released a recall alert for class I medical Device– Arrow AutoCAT®2 and AC3 Optimus® IABP Series due to possible breakdown of motor connector wires.

Device Use:

The Arrow AutoCAT®2 and AC3 Optimus® are Intra-Aortic Balloon Pumps (IABP) are cardiac assist devices which are used for patients who are undergoing cardiac and non-cardiac surgery, and in the treatment of patients with acute coronary syndrome or complications from heart failure.

Recall Reason:

The manufacturer of this medical device, Arrow International is recalling the Arrow AutoCAT®2 Intra-Aortic Balloon Pump and AC3 Optimus® Intra-Aortic Balloon Pump Series because both devices have a part within called the MForce motor driver which might break, char, and discolor the motor connector wires. This could lead to pump alarms for “System Error 3” and “High Baseline” presented on the screen of the IABP. Furthermore, the IABP may suddenly stop, even without an alarm. This can cause a serious harm to the patient which included serious organ damage and death.

Device Incident reports:

The manufacturer has received 30 medical device incidents (complaints) in total pertaining to these devices. However, there were no complaints which reported any injuries or deaths.

Class I MD recall: This device falls under the category of Class I medical device, as per the classification system by US-FDA. This is the most serious type of recall because use of these devices might cause serious injuries or death.

Recalled Devices:

On 20-May-2020, Arrow International initiated the recall for 2123 medical devices which were manufactured during 01-Aug-2014 to Jan-2020 and distributed between 15-Mar-2018 and 01-May-2020. Lots affected with device recall are listed here.

Key information from Arrow International Inc:

On 20-May-2020, this device manufacturer sent an Urgent Medical Device Correction letter to all affected customers with the below instructions.

  • To check immediately the inventory for Arrow® AutoCAT®2 and Arrow® AC3 Optimus® IABPs, whether stored or in use, and determine if there is an IABP with a model number listed below.
    • If the IABP mentioned in the Urgent Medical Device Correction letter displays a “System Error 3” or “High Baseline” alarm, now or at any point in the future until the company’s Long-Term Corrective Actions specified in the letter occur, immediately quarantine the device and contact Teleflex.
  • To 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.
  • To use a backup IABP or alternative therapy in the event an IABP displays a “System Error 3” or “High Baseline” alarm, at the discretion of the attending physician.
  • Closely monitor IABP units should be during delivery of IABP therapy.
  • Use of IABP for ground or air transport between medical facilities is not recommended.
  • If pump shutdown is experienced, take note of the time of day and call knowledgeable maintenance personnel as stated in the Arrow® AutoCAT®2 Intra-Aortic Balloon Pump / Arrow® AC3 Optimus® Intra-Aortic Balloon Pump Operator Manuals.
    • Pump shutdown requires immediate staff action. If pumping cannot be restored within 15-30 minutes, manually inflate, and deflate the IAB several times per hour to reduce the risk of thrombus formation. Consider removing the balloon. Arrow International recommends there be a back-up IABP system available.
  • Keep a copy of the Urgent Medical Device Correction letter from Arrow International with each IABP at all times until the complete implementation of the company’s Long-Term Corrective Actions specified in the letter.
  • Quarantine the device for inspection, if “System Error 3” and “High Baseline” alarms are experienced at a later time, taking into consideration the use of available alternative therapies, and adhering to the instructions specified under the heading “ACTIONS TO BE TAKEN BY FACILITIES” in the Urgent Medical Device Correction letter.

Arrow International Inc. will send a subsequent notification letter to affected customers with updated instructions for ground or air transport use. Instructions will replace a uniform “Not Recommended for Transport” statement with a risk benefit analysis, use of a backup device, and recommendation to use a newer manufactured device.

For Queries on this Device Recall: Health care professionals and distributors can contact Arrow International through following channels for queries or support for inspection and servicing of the impacted device.

Via Phone: 1-855-419-8507

Via email:[email protected]

Voluntary MDI (Medical Device Incident) reporting:

Health care professionals and consumers are advised to report the adverse reactions or quality problems experienced with the use of this medical device to the FDA’s MedWatch Adverse Event Reporting program either online, by regular mail, or by fax.

  • Complete and voluntarily submit the report Online.
  • Regular Mail or Fax: Download form FDA’s MedWatch zone, or call 1-800-332-1088 to request a reporting form, then complete and return to the address on the pre-addressed form, or submit by fax to 1-800- FDA-0178.
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