The Recall Desk
Agency classClass IIOur severity:ModerateFDA (Devices)·Z-2302-2013·Announced 2013-10-09

Medtronic NC Sprinter Balloon Catheter Recalled for Incorrect Size Labeling

Medtronic is recalling 122 units of NC Sprinter Balloon Dilatation Catheters because the compliance chart lists the size as 2.5mm instead of the correct 2.25mm.

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 Moderate because it involves a minor labeling error on the compliance chart, which falls under the rubric criteria for minor labeling errors.

Plain-English summary

Medtronic Vascular, Inc. is recalling 122 units of the NC Sprinter Rapid Exchange Balloon Dilatation Catheter, Model NCSP22512X. The affected devices are sterile, 2.25 mm in size, and belong to lot number 207002011 with an expiration date of May 13, 2015.

The recall was initiated because the compliance chart included in the lot incorrectly lists the device size as 2.5 mm instead of the correct 2.25 mm. This is a labeling error on the documentation provided with the product.

The affected units were distributed worldwide, including in the United States, Australia, Belgium, Canada, Hong Kong, Malaysia, New Zealand, Singapore, Spain, Switzerland, Taiwan, and Thailand. Healthcare providers and distributors should stop using the affected units and contact Medtronic for instructions on return or replacement.

The recalled product

Product
NC Sprinter; Rapid Exchange Balloon Dilatation Catheter; Sterile; 2.25 mm; Model NCSP22512X. Manufacturer: Medtronic, Inc. 710 Medtronic Parkway Minneapolis, MN 55432 The NC Sprinter Rapid Exchange Balloon Dilatation Catheter is a Percutaneous Transluminal Coronary…
Manufacturer
Medtronic Vascular, Inc.
Category
Medical Device — Cardiovascular
Hazard
Affected units
122

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)

  • Lot number 207002011
  • Exp 5-13-2015.

Distribution

Distribution scope not specified by the agency.

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