CLASS II Device recall · Reported 11 Dec 2013 · FDA Enforcement Report

Navigator HD l3F/15F Ureteral Access Sheath Set Product No recalled

Boston Scientific is recalling Navigator HD l3F/15F Ureteral Access Sheath Set Product No M0062502280, RDF, distributed nationwide in the US. The recall was initiated on 5 Nov 2013 and the FDA has classified it as Class II.

Check your package

Lot, batch or date codesUPN M0062502280, Catalog 250-228, Lot 15753725,15819257,15840833,1587719, 15918445,15931128, 16008343,16015286, 16065866,16141201, 16295107,16319657

Quantity recalled939

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-0441-2014
FDA event ID: 66828
Recalling firm: Boston Scientific, Marlborough, MA
Classification: Class II
Status: Terminated
Recall initiated: 5 Nov 2013
FDA classified: 4 Dec 2013
Reported: 11 Dec 2013
Type: Voluntary: Firm initiated
Customers notified by: Letter
Reason category: Other Reasons
Device type: Surgical Instruments

Timeline

5 Nov 2013	Recall initiated by company
4 Dec 2013	Classified by FDA	+29 days
11 Dec 2013	Published in enforcement report	+7 days

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

Reason for recall

The 13F/15F Navigator HD Ureteral Access SheathSet are being recalled after receipt of 5 reports where the tip of the dilator has separated fro the body of the dilator.

Product as listed by the FDA

Navigator HD l3F/15F x 36cm Ureteral Access Sheath Set Product No M0062502280, RDF Catalog No 250-228, Sterile. Indicated for use in endoscopic procedures to facilitate the passage of endoscopes, urological instruments and for the injection of fluids into the urinary tract.

Where it was distributed

Worldwide Distribution-USA (nationwide) including Puerto Rico and the countries of Australia, Ireland, Denmark, Italy, France, Canada, Great Britain, Switzerland, South Africa, Germany, and the Netherlands.

Nationwide Puerto Rico

Questions about this recall

Why was it recalled?

The 13F/15F Navigator HD Ureteral Access SheathSet are being recalled after receipt of 5 reports where the tip of the dilator has separated fro the body of the dilator.

Which lots are affected?

UPN M0062502280, Catalog 250-228, Lot 15753725,15819257,15840833,1587719, 15918445,15931128, 16008343,16015286, 16065866,16141201, 16295107,16319657

Where was it sold?

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

2 other products · FDA event 66828

This product is part of a recall event; the main page for the event is Navigator HD l3F/15F Ureteral Access Sheath Set Product No recalled.

Reported	Class	Recall	Company	Reason	Where
11 Dec 2013	CLASS II	Navigator HD l3F/15F Ureteral Access Sheath Set Product No recalled	Boston Scientific	Other	Nationwide
11 Dec 2013	CLASS II	Navigator HD l3F/15F Ureteral Access Sheath Set Product No recalled	Boston Scientific	Other	Nationwide

More recalls from Boston Scientific

All 626

Reported	Class	Recall	Company	Reason	Where
9 Sep 2026Device	CLASS II	Lux-Dx, Lux-Dx II, Lux-Dx II+ Insertable Cardiac Monitor recalled	Boston Scientific	Device Malfunction	Nationwide
9 Sep 2026Device	CLASS II	Lux-Dx, Lux-Dx II, Lux-Dx II+ Insertable Cardiac Monitor recalled	Boston Scientific	Device Malfunction	Nationwide
9 Sep 2026Device	CLASS II	Lux-Dx, Lux-Dx II, Lux-Dx II+ Insertable Cardiac Monitor recalled	Boston Scientific	Device Malfunction	Nationwide
26 Aug 2026Device	CLASS I	Enroute Transcarotid Neuroprotection System recalled	Boston Scientific	Other	Nationwide
26 Aug 2026Device	CLASS I	Enroute Transcarotid Neuroprotection System Plus recalled	Boston Scientific	Other	Nationwide

Other Surgical Instruments recalls

All 3,809

Reported	Class	Recall	Company	Reason	Where
9 Sep 2026Device	CLASS II	Medline Convenience Kits: IV Start KIT recalled by Medline Industries	Medline Industries	Sterility	Nationwide
9 Sep 2026Device	CLASS II	Medline Convenience Kits containing BD ChloraPrep Clear recalled	Medline Industries	Packaging Defects	Nationwide
2 Sep 2026Device	CLASS II	Medline convenience kits labeled as: Open Heart Pack, Medline Kit recalled	Medline Industries	Other	Nationwide
2 Sep 2026Device	CLASS II	Medline convenience kits labeled as: GYN Robotic CDS, Medline Kit recalled	Medline Industries	Other	Nationwide
2 Sep 2026Device	CLASS II	Linvatec Genesys CrossFT Suture Anchor with Disposable Driver recalled	ConMed	Other	Nationwide