Medtronic Resolute Integrity Coronary Stent Recall for Incorrect Compliance Chart Labeling
Medtronic is recalling 201 units of Resolute Integrity Zotarolimus-eluting Coronary Stents because the compliance chart may incorrectly reference a 2.25 mm diameter instead of the correct 3.0 mm.
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 2/5 (Moderate).
Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.
Our severity reasoning: The recall is classified as FDA Class II, but the hazard is a minor labeling error (incorrect diameter on a compliance chart) with no reported injuries or illnesses, fitting the criteria for a moderate severity score.
Plain-English summary
Medtronic Vascular, Inc. is recalling 201 units of the Resolute Integrity Zotarolimus-eluting Coronary Stent System. The affected units are from lot number 0006573585, with a stent internal diameter of 3.0 mm and a length of 34 mm. These devices were manufactured in Medtronic Ireland, Galway, Ireland, and distributed nationwide by Medtronic Inc. in Minneapolis, MN.
The recall was initiated because a small number of units in the affected lot may contain a compliance chart that incorrectly references a 2.25 mm diameter instead of the correct 3.0 mm diameter. The agency has classified this as a Class II recall.
The source text does not specify specific actions for consumers or healthcare providers, nor does it report any illnesses or injuries associated with this labeling error.
The recalled product
- Product
- Resolute Integrity Zotarolimus-eluting Coronary Stent: Stent ID 3.0 mm; Stent length 34 mm; Rx, Sterile. Mfg in Medtronic Ireland, Galaway, Ireland. Distributed by: Medtronic Inc. Minneapolis, MN. Indicated for improving coronary luminal diameters in patients.
- Manufacturer
- Medtronic Vascular, Inc.
- Category
- Medical Device — Cardiovascular
- Hazard
- Affected units
- 201
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 (2)
- Model: RSINT30034UX
- Customer Facing Number: RSIST30034UX. Expiration date: 25 May 2014.
Distribution
Distributed nationwide across the United States.
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