Medtronic Sphera DR MRI SureScan Pacemakers Recalled for Circuit Error
Medtronic is recalling specific Sphera DR MRI SureScan pacemakers worldwide due to a circuit error that may affect device functionality when programmed to dual chamber mode.
The agency’s classification
FDA (Devices): Class I
Class I is a situation in which there is a reasonable probability that the use of or exposure to a violative product will cause serious adverse health consequences or death.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 4/5 (Severe).
The hazard poses a serious risk of illness, injury, or structural failure. Stop using the product immediately and contact the manufacturer for a refund or repair.
Our severity reasoning: The agency classified this recall as Class I — a situation in which there is a reasonable probability that the use of or exposure to a violative product will cause serious adverse health consequences or death. On that classification alone this is scored Severe; a score of Critical is reserved for recalls where a death or serious injury was reported. The agency gives the reason as: "A subset of Medtronic dual chamber pacemakers distributed worldwide between 10 March 2017 and 7 January 2019 under the brand names Adapta, Versa, and Sensia when programmed to a dual chamber mode with atrial-sensing, may experience a…"
Plain-English summary
Medtronic Inc. is recalling a subset of Sphera DR MRI SureScan dual chamber rate responsive pacemakers (DDDR) distributed worldwide between March 10, 2017, and January 7, 2019. The affected units include Model Numbers SPDR01 and SPDRL1, which were distributed under the brand names Adapta, Versa, and Sensia.
The recall is due to a potential circuit error that may affect device functionality. This issue may occur when the pacemaker is programmed to a dual chamber mode with atrial-sensing. The source text does not specify the exact nature of the functional impact or report any specific injuries or illnesses associated with this defect.
Patients with these specific pacemaker models should contact their healthcare provider or Medtronic for guidance on next steps. The recall covers 5,392 units across all serial numbers for the specified model numbers.
The recalled product
- Product
- Medtronic implantable pulse generator: Sphera DR MRI SureScan, Dual chamber rate responsive pacemaker (DDDR): (a) Model Number SPDR01 (b) Model Number SPDRL1
- Category
- Medical Device — Pacemaker
- Hazard
- Affected units
- 5,392
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (8)
- Sphera DR MRI SureScan
- Dual chamber rate responsive pacemaker (DDDR): (a) Model Number SPDR01
- GTIN 00643169882959
- 00763000109097
- All Serial Numbers (b) Model Number SPDRL1
- GTIN 00643169882966
- 00763000109103
- All Serial Numbers
Distribution
Distribution scope not specified by the agency.
Part of a larger recall action
This product is one of 7 recalled by Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF) under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
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