The Recall Desk
Agency classClass IIOur severity:HighFDA (Devices)·Z-0045-2014·Announced 2013-10-30

Merit Medical Recalls Performa Angiographic Catheters Due to Tip Shape Variation

Merit Medical Systems is recalling 200 units of Performa Angiographic Catheters because four lots contain a catheter with a slight variation in tip shape.

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 is classified as FDA Class II. Per the rubric, FDA Class II recalls without explicit reports of hospitalization or injury are scored as High (3), as they represent a risk of harm where injury has not yet been reported.

Plain-English summary

Merit Medical Systems, Inc. is recalling 200 units of the Performa Angiographic Catheter 5F Multipack. The affected products include part numbers 7560-43 and 7560-G3. The recall involves four specific lots: 7560-43/I663860, 7560-43/I663861, 7560-G3/I664519, and 7560-G3/I666388.

The recall was initiated because four lots of the Performa Cardiac Multipacks contain a JR4.0 catheter with a slight variation in tip shape. The FDA has classified this recall as Class II, indicating a situation where use of, or exposure to, the violation may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote.

The affected products were distributed in the United States, including the states of Colorado, Virginia, and Mississippi. Healthcare providers and facilities should check their inventory for the specific part and lot numbers listed above and stop using the affected devices.

The recalled product

Product
Merit Medical Performa Angiographic Catheter 5F Multipack. Part numbers 7560-43 and 7560-G3.
Manufacturer
Merit Medical Systems, Inc.
Category
Medical Device — Catheter
Hazard
Affected units
200

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 (3)

  • Part Number/Lot Number: 7560-43/I663860
  • 7560-43/I663861
  • 7560-G3/I664519 and 7560-G3/I666388.

Distribution

Distributed in 3 states:

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