Medtronic Recharger Kits Recalled for Potential Failure to Initiate Recharging
Medtronic is recalling 118 wireless recharger kits for implantable neurostimulators because they may fail to start a recharging session upon first use.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
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 3/5 (High).
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: The recall involves a medical device that may fail to recharge an implanted neurostimulator, posing a risk of harm to patients, although no specific injuries or illnesses have been reported in the source text.
Plain-English summary
Medtronic Neuromodulation is recalling 118 wireless recharger kits, including models RS6230, RS7230, and RS5220A, which contain components WR9230 and WR9220A. These rechargers are used with specific rechargeable implantable neurostimulators, including the Inceptiv INS Model 977119, Percept RC INS Model B35300, and InterStim Micro Model 97810, as part of Deep Brain Stimulation and Pelvic Health systems.
The recall is due to a defect where the wireless rechargers may be unable to enter a recharging session upon first use. This issue could prevent patients from recharging their implanted devices as intended.
The affected units were distributed worldwide, including in the United States and various countries in Europe and Asia. Patients using these specific recharger kits should contact Medtronic or their healthcare provider for instructions on how to proceed.
The recalled product
- Product
- Medtronic Recharger Kits, RS6230, RS7230, and RS5220A, containing components WR9230 and WR9220A Recharger for rechargeable implantable neurostimulators. The Rechargers are used with Neurostimulator Inceptiv INS Model 977119 and Percept RC INS Model B35300 as part of the Deep…
- Manufacturer
- Medtronic Neuromodulation
- Affected units
- 118
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 (20)
- RS6230 - GTIN 00763000564353
- Serial numbers: NRA010637N
- NRA011389N
- NRA013260N
- NRA013664N
- NRA013924N
- NRA014318N
- NRA014347N
- NRA015823N
- NRA015861N
- NRA015864N
- NRA016334N
- NRA016413N
- NRA016430N
- NRA016432N
- NRA016778N
- RA017002N
- NRA017048N
- NRA017227N
- NRA017232N
Distribution
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