Medtronic Medical Device Identification Card for SureScan pacemaker patients. The front of this card identifies the impl
FDA device recall Z-0022-2016 · posted 2015-10-05 · Terminated
Recall details
- Recalling firm
- Medtronic Inc. Cardiac Rhythm Disease Management
- Reason for recall
- Some Medical Device Identification Cards provided to SureScan pacemaker patients indicate they have a complete Magnetic Resonance (MR) Conditional system, when in fact, not all of their implanted leads have been FDA approved as MR Conditional.
- Action taken
- On September 15, 2015, Medtronic began mailing an Important Medical Device Identification Card Notification letter, including a corrected Medical Device Identification Card, to impacted patients. The letter described the issue, provided a new corrected Identification Card, asked that the old card be destroyed immediately, and to begin using the new card. Patients can contact Medtronic Patient Services at 1-800-551-5544, option 1, followed by option 3, Monday - Friday, 8am - 5pm Central time.
- Root cause
- Process control
- Status
- Terminated
- Product code
- DTB
- Quantity affected
- 777 cards
- Distribution
- US nationwide distribution.
- Date initiated
- 2015-09-15
- Date posted
- 2015-10-05
- Date terminated
- 2016-04-14
- Location
- Saint Paul, MN
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Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| MEDTRONIC MODEL 4558M (K940703) | Medtronic Vascular | 1994-11-04 |
| MEDTRONIC MODELS 4057M,4058M,4557M, PACING LEADS (K932172) | Medtronic Vascular | 1993-12-08 |
| MEDTRONIC MODEL 4058 PACING LEAD (K883743) | Medtronic Vascular | 1989-01-17 |