Recall image placeholder

No image published for this recall

Cre™ wireguided and cre pro™ wireguided balloon dilation catheters

Official notice

29 May 2026

Last checked

29 May 2026

Medium riskHealth Canada
Watch Boston Scientific

An official Health Canada notice concerns Cre™ wireguided and cre pro™ wireguided balloon dilation catheters. Boston Scientific is initiating removal of CRE™ Wireguided and CRE PRO™ Wireguided balloon dilation catheters due to a potential sterile breach of the pouches in which the devices are packaged. These catheter products are primarily used to endoscopically dilate strictures of the alimentary tract. Published 2026-05-29.

What to do now

Contact the manufacturer if you require additional information.

Recall number

82136

Official notice

2026-05-29

The hazard

Boston Scientific is initiating removal of CRE™ Wireguided and CRE PRO™ Wireguided balloon dilation catheters due to a potential sterile breach of the pouches in which the devices are packaged. These catheter products are primarily used to endoscopically dilate strictures of the alimentary tract.

How to check if you're affected

Compare the VIN on your vehicle against the official list. If your VIN is listed, follow the official notice.

Skus

M00558680, M00558690, M00558660, M00558670, M00558700, M00558710

Other

RA RA-82136

Model Numbers

M00558680, M00558690, M00558660, M00558670, M00558700, M00558710

Recall Numbers

82136

Checked manually this time?

The app watches your VIN and alerts you automatically next time — no searching, no checking back.

Turn on automatic VIN checks

Affected products

Product 1

Lot or serial number - More than 10 numbers, contact manufacturer., Model or catalogue number - M00558680

Product 2

Lot or serial number - More than 10 numbers, contact manufacturer., Model or catalogue number - M00558690

Product 3

Lot or serial number - More than 10 numbers, contact manufacturer., Model or catalogue number - M00558660

Product 4

Lot or serial number - More than 10 numbers, contact manufacturer., Model or catalogue number - M00558670

Product 5

Lot or serial number - More than 10 numbers, contact manufacturer., Model or catalogue number - M00558700

Product 6

Lot or serial number - More than 10 numbers, contact manufacturer., Model or catalogue number - M00558710

Risk / hazard

Boston Scientific is initiating removal of CRE™ Wireguided and CRE PRO™ Wireguided balloon dilation catheters due to a potential sterile breach of the pouches in which the devices are packaged. These catheter products are primarily used to endoscopically dilate strictures of the alimentary tract.

Where it was sold

The source does not list specific retailers. See the official notice for where affected vehicles were sold.

Location 1

CA · Canada

Affected area 1

CA · Canada

Company & contacts

Brand

Boston Scientific

Manufacturer

Not provided

Phone

Not provided

Brand: Boston Scientific.

Source & status

Source

Health Canada

Tier

official

Category

HOME

Classification

Type II

App estimate

medium

Recall details

Recall number

82136

Classification

Type II

Source tier

official

Documents, notices & source

See the official notice and source documents for full details.

View full official notice
Something wrong on this page?

Related recalls

CA
Recall image placeholder

Nephromax high pressure nephrostomy balloon catheter

Medium riskHealth Canada2 Jul 2026
CA
Recall image placeholder

Hot axios™ stent and electrocautery-enhanced delivery system

High riskHealth Canada23 Dec 2025
CA
Recall image placeholder

Ams 700™ inflatable penile prosthesis with tenacio™ pump

Medium riskHealth Canada25 Sept 2025
CA
Recall image placeholder

Iceseed 1.5 cx 90 needle

Medium riskHealth Canada28 Apr 2025
CA
Recall image placeholder

Hot axios™ stent and electrocautery enhanced delivery system

Medium riskHealth Canada8 Jan 2025
CA
Recall image placeholder

Wallflex™ esophageal fully covered partially covered stent systems

Medium riskHealth Canada21 Aug 2024
CA
Recall image placeholder

Capio™ slim suture capturing device

Medium riskHealth Canada8 Jul 2024
CA
Recall image placeholder

Autotome rx

Critical riskHealth Canada3 Jul 2024
CA
Recall image placeholder

Exalt model d single-use duodenoscope

Medium riskHealth Canada18 Oct 2023
CA
Recall image placeholder

Habib™ endohpb catheter

Medium riskHealth Canada16 Mar 2023
CA
Recall image placeholder

A.t.s® 4000 ts tourniquet systems single and dual hose with cpc connectors

Medium riskHealth Canada23 Jun 2026
CA
Recall image placeholder

Faradrive™ steerable sheath

Medium riskHealth Canada19 Jun 2026

Weekly recall digest

Get next week's recalls before you need them.

One email every Monday — official-source recalls for your country, and nothing else. Unsubscribe from any email.

The digest is the slow lane — one email a week. For instant, severity-gated alerts the moment a notice is published, get the app.

This recall was published 29 May 2026. The next one won't wait for you to search.

RecallScope watches official sources for the brands and VINs you follow, and alerts you the moment a new notice is published.