CLASS II Device recall · Reported 17 Jul 2013 · FDA Enforcement Report

NephroMax high Pressure Nephrostomy Balloon Catheter recalled

Boston Scientific is recalling NephroMax high Pressure Nephrostomy Balloon Catheter, distributed nationwide in the US. The recall was initiated on 28 May 2013 and the FDA has classified it as Class II.

Check your package

Lot, batch or date codesLot Number: 15875861, 15875860, 15875299, 15872797, 15872799, 15872798

Quantity recalled27

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

Recall details

Recall number: Z-1672-2013
FDA event ID: 65317
Recalling firm: Boston Scientific, Marlborough, MA
Classification: Class II
Status: Terminated
Recall initiated: 28 May 2013
FDA classified: 9 Jul 2013
Reported: 17 Jul 2013
Type: Voluntary: Firm initiated
Customers notified by: Letter
Reason category: Packaging Defects
Device type: Heart & Vascular Devices

Timeline

28 May 2013	Recall initiated by company
9 Jul 2013	Classified by FDA	+42 days
17 Jul 2013	Published in enforcement report	+8 days

Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.

Reason for recall

Incorrect sized renal sheath was packaged with the NephroMax high pressure nephrostomy Balloon Catheter.

Packaging recalls include wrong labels, wrong products in the wrong bottle, missing leaflets, short-filled or empty capsules and seals that fail.

Product as listed by the FDA

NephroMax high Pressure Nephrostomy Balloon Catheter. Material Number/Catalog Number: M0062101400/210-140, M062101440/210144 Dilation of the nephrostomy tract.

Where it was distributed

Worldwide distribution: USA (nationwide) including states of: NJ, NY, OH, IL, MI, MD, MA and countries of: Denmark, Great Britain, and Spain.

Nationwide Illinois Massachusetts Maryland Michigan New Jersey New York Ohio

Questions about this recall

Why was it recalled?

Incorrect sized renal sheath was packaged with the NephroMax high pressure nephrostomy Balloon Catheter.

Which lots are affected?

Lot Number: 15875861, 15875860, 15875299, 15872797, 15872799, 15872798

Where was it sold?

Worldwide distribution: USA (nationwide) including states of: NJ, NY, OH, IL, MI, MD, MA and countries of: Denmark, Great Britain, and Spain.

What should I do if I have it?

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

What does Class II mean?

Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.

Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.

Other products in this recall event

1 other product · FDA event 65317

This product is part of a recall event; the main page for the event is NephroMax high Pressure nephrostomy Balloon Catheter Kit recalled.

Reported	Class	Recall	Company	Reason	Where
17 Jul 2013	CLASS II	NephroMax high Pressure nephrostomy Balloon Catheter Kit recalled	Boston Scientific	Packaging Defects	Nationwide

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