Medtronic Dual Chamber Temporary External Pacemaker, Model 5392. Product Usage: The temporary pacemaker is used with a c
FDA device recall Z-1356-2015 · posted 2015-03-31 · Terminated
Recall details
- Recalling firm
- Medtronic Inc. Cardiac Rhythm Disease Management
- Reason for recall
- Possible performance issue when used with specific AA-sized (LR6) batteries. The negative terminal of a commercially available AA (LR6) battery did not maintain a sufficient connection with the battery drawer electrical contact. This issue could prevent the EPG from powering on or cause the EPG to abruptly lose primary battery power, potentially stopping delivery of pacing therapy.
- Action taken
- Medtronic sent an "Urgent Medical Device Correction" letter dated March 2015 to affected customers. The letter was addressed to Risk Manager or Health Care Professional. The letter described the Issue and Customer Actions to be taken. The letter requested customers to complete and return the Customer Confirmation Certificate. For questions contact your Medtronic representative, for technical questions call Instrument Technical Service at 800-638-1991.
- Root cause
- Device Design
- Status
- Terminated
- Product code
- DTE
- Quantity affected
- 6040 devices
- Distribution
- Worldwide Distribution - US Nationwide in the states of: AL, AK, AZ, AR, CA, CO, CT, DC, FL, GA, ID, IL, IN, KS, KY, LA, MA, MI, MM, MS, MO, MT, NE NV,N, NM, NY, NC, ND, OH,OK, PA, RI, SC, TN, TX, UT,
- Date initiated
- 2015-03-17
- Date posted
- 2015-03-31
- Date terminated
- 2015-10-08
- Location
- Saint Paul, MN
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Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| Medtronic Model 5392 External Pulse Generator (EPG) (K150246) | Medtronic, Inc. | 2015-02-18 |
| MEDTRONIC EXTERNAL PULSE GENERATOR (EPG) (K132924) | Medtronic, Inc. | 2013-10-31 |