Crome Implantable Cardioverter Defibrillators may deliver reduced shock energy
Medtronic recalls 866 Crome implantable defibrillators due to potential reduced shock energy delivery during high-voltage therapy, affecting devices worldwide. Patients should contact their physician to determine if their device is affected.
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: FDA Class I medical device recall. The rubric specifies that FDA Class I classifications never go below a severity score of 4. No deaths or serious injuries have been reported, placing this at score 4 rather than 5.
Plain-English summary
Medtronic is recalling 866 Crome implantable cardioverter defibrillators (ICD) with cardiac resynchronization therapy (CRT-D) due to a potential malfunction in shock energy delivery. This recall applies to Crome HF CRT-D (Models DTPC2D4 and DTPC2D1) and Crome HF Quad CRT-D (Models DTPC2QQ and DTPC2Q1).
The devices may deliver reduced shock energy—approximately 79% of the programmed energy level—during high-voltage therapy. This reduced energy could prevent the device from delivering the full intended therapy dose when needed to treat dangerous heart rhythms.
The affected devices have been distributed worldwide. Medtronic has identified specific affected serial numbers by model number and GTIN code to enable precise device identification.
Patients with affected devices should contact their physician immediately to determine whether their device is affected and to discuss recommended actions. Healthcare providers should consult Medtronic regarding corrective options, which may include device monitoring, reprogramming, or replacement.
The recalled product
- Product
- Crome Implantable Cardioverter Defibrillators with Cardiac Resynchronization Therapy (CRT-D): a. Crome HF CRT-D, Model Numbers: DTPC2D4, DTPC2D1; b. Crome HF Quad CRT-D, Model Numbers: DTPC2QQ, DTPC2Q1
- Affected units
- 866
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)
- a. Model Numbers: DTPC2D4: GTIN 00763000178291
- Serial Numbers: RTW600120S
- RTW600307S
- GTIN 00763000178314
- Serial Numbers: RTW600018S
- RTW600020S
- RTW600022S
- RTW600025S
- RTW600027S
- RTW600028S
- RTW600029S
- RTW600032S
- RTW600033S
- RTW600034S
- RTW600038S
- RTW600040S
- RTW600041S
- RTW600045S
- RTW600232S
- RTW600316S
Distribution
Distribution scope not specified by the agency.
Part of a larger recall action
This product is one of 6 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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