The Recall Desk
Agency classClass IIOur severity:ModerateFDA (Devices)·Z-1375-2016·Announced 2016-04-20

Merit Medical Recalls TSX Transseptal Needle Due to Labeling Error

Merit Medical Systems is recalling one lot of TSX Transseptal Needles because the packaging labels incorrectly state a 50-degree curve instead of the actual 86-degree curve.

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 and involves a labeling discrepancy regarding device configuration. Per the rubric, minor labeling errors and voluntary precautionary recalls without reported injuries fall under the Moderate severity level.

Plain-English summary

Merit Medical Systems, Inc. is voluntarily recalling one lot of the TSX Transseptal Needle, Model Number M004TSX60o. The recall is due to a discrepancy between the device labeling and the actual configuration of the device in the packaging.

The curve dimensional values on the labels for this specific lot incorrectly indicate a 50-degree curve, whereas the actual device configuration is an 86-degree curve. The affected lot is identified as Lot Q823423 with an expiration date of 7/31/2018.

The recall involves 25 units that were distributed to one customer in the United States. The TSX Transseptal Needle is used to create the primary puncture in the interatrial septum when passing an intruder and/or catheter through the septum from the right side of the heart to the left side.

The recalled product

Product
Boston Scientific TSX Transseptal Needle, Model Number M004TSX60o; Used to create the primary puncture in the interatrial septum when passing an intruder and/or catheter through the septum from the right side of the heart to the left side.
Manufacturer
Merit Medical Systems, Inc.
Category
Medical Device — Cardiac Catheterization
Hazard
Affected units
25

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 Q823423
  • Exp 7/31/2018

Distribution

Distribution scope not specified by the agency.

Related recalls

Same manufacturer · Merit Medical Systems, Inc.

See all →

Same hazard · mis labeling

See all →

Similar recalls