Device recall: Dreamtome RX Cannulating Sphincterotome-DREAMTOME 44-20MM/260CM Material Number: M00584040

Class II FDA enforcement event 89468. Recall start date: 22 Dec 2021. Status in the FDA record: Ongoing.

Reason for recall, in the words of FDA

Sterility of device is compromised due to a sterile barrier breach

Class II, in the words of FDA

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

Boston Scientific Corporation started this device recall on 22 Dec 2021. The firm address in the FDA record is in Marlborough, MA. FDA put the recall in Class II. FDA event 89468 has 31 product records. The first FDA enforcement report date is 23 Mar 2022. The record gives the status Ongoing.

FDA enforcement report The 31 product records

It is important to note that most of the time recall classifications are determined after the recalling firm provides all of the information needed to determine the risk posed to public health. The classification and posting in the FDA Enforcement Report should not be seen as an expansion or change to a firm’s voluntary public warning.
FDA publishes these words. Source: FDA, Enforcement Reports, Important Note, read on 1 Oct 2026. openFDA export of 28 Sep 2026.

Distribution

In the words of FDA.

Worldwide distribution - US Nationwide and the countries of Australia, Austria, Belgium, Canada, Botswana, China, Czech Republic, Denmark, Finland, France, Germany, Great Britain, Greece, Ireland,…

Recalling firm

Boston Scientific Corporation, Marlborough, MA.

Recalling firm: The firm that the FDA record names for a recall.

FDA records how the recall started: Voluntary: Firm initiated.

Products

31 product records in the event.

FDA event 89468: product records
Recall number	Product	Quantity	Class	Status	Report date
Z-0751-2022	Dreamtome RX Cannulating Sphincterotome-DREAMTOME 44-20MM/260CM Material Number: M00584040	21309 units	Class II	Ongoing	23 Mar 2022
Z-0752-2022	Dreamtome Cannulating Sphincterotome-DREAMTOME 44-20MM/450CM Material Number: M00584060	1811 units	Class II	Ongoing	23 Mar 2022
Z-0753-2022	DREAMTOME 44-30MM/260CM Material Number: M00584050	12067 units	Class II	Ongoing	23 Mar 2022
Z-0754-2022	DREAMTOME 44-30MM/450CM Material Number: M00584070	142 units	Class II	Ongoing	23 Mar 2022
Z-0755-2022	DREAMTOME 49-20MM/260CM Material Number: M00584000	982 units	Class II	Ongoing	23 Mar 2022
Z-0756-2022	DREAMTOME 49-20MM/450CM Material Number: M00584020	15 units	Class II	Ongoing	23 Mar 2022
Z-0757-2022	DREAMTOME 49-30MM/260CM Material Number: M00584010	472 units	Class II	Ongoing	23 Mar 2022
Z-0758-2022	DREAMTOME 49-30MM/450CM Material Number: M00584030	32 units	Class II	Ongoing	23 Mar 2022
Z-0759-2022	HYDRATOME RX 44-20MM/260CM Material Number: M00583040	7695 units	Class II	Ongoing	23 Mar 2022
Z-0760-2022	HYDRATOME RX 44-20MM/450CM Material Number: M00583060	254 units	Class II	Ongoing	23 Mar 2022
Z-0761-2022	HYDRATOME RX 44-30MM/260CM Material Number: M00583050	3371 units	Class II	Ongoing	23 Mar 2022
Z-0762-2022	HYDRATOME RX 44-30MM/450CM Material Number: M00583070	251 units	Class II	Ongoing	23 Mar 2022
Z-0763-2022	HYDRATOME RX 49-20MM/260CM Material Number: M00583000	112 units	Class II	Ongoing	23 Mar 2022
Z-0764-2022	HYDRATOME RX 49-30MM/260CM Material Number: M00583010	N/A	Class II	Ongoing	23 Mar 2022
Z-0765-2022	JAGTOME REVOLUTION RX 39-20-260-025 Material Number: M00584240	7115 units	Class II	Ongoing	23 Mar 2022
Z-0766-2022	JAGTOME REVOLUTION RX 39-20-450-025 Material Number: M00584250	68 units	Class II	Ongoing	23 Mar 2022
Z-0767-2022	JAGTOME REVOLUTION RX 39-30-260-025 Material Number: M00584260	3330 units	Class II	Ongoing	23 Mar 2022
Z-0768-2022	JAGTOME RX 39-20-260-025 Material Number: M00573080	4487 units	Class II	Ongoing	23 Mar 2022
Z-0769-2022	JAGTOME RX 39-20-450-025 Material Number: M00573090	367 units	Class II	Ongoing	23 Mar 2022
Z-0770-2022	JAGTOME RX 39-30-260-025 Material Number: M00573100	1447 units	Class II	Ongoing	23 Mar 2022
Z-0771-2022	JAGTOME RX 39-30-260-025 Material Number: M00573100	98 units	Class II	Ongoing	23 Mar 2022
Z-0772-2022	JAGTOME RX 39-30-450-025 Material Number: M00573110	98 units	Class II	Ongoing	23 Mar 2022
Z-0773-2022	JAGTOME RX 44-20-260-035 Material Number: M00573040	3578 units	Class II	Ongoing	23 Mar 2022
Z-0774-2022	JAGTOME RX 44-20-450-035 Material Number: M00573050	3578 units	Class II	Ongoing	23 Mar 2022
Z-0775-2022	JAGTOME RX 44-30-260-035 Material Number: M00573060	2209 units	Class II	Ongoing	23 Mar 2022
Z-0776-2022	JAGTOME RX 44-30-450-035 Material Number: M00573070	163 units	Class II	Ongoing	23 Mar 2022
Z-0777-2022	JAGTOME RX 49-20-260-035 Material Number: M00573000	101 units	Class II	Ongoing	23 Mar 2022
Z-0778-2022	JAGTOME RX 49-30-260-035 Material Number: M00573020	96 units	Class II	Ongoing	23 Mar 2022
Z-0779-2022	JAGTOME RX 49-30-450-035 Material Number: M00573030	14 units	Class II	Ongoing	23 Mar 2022
Z-0780-2022	RX CHOLANGIOGRAM KIT Material Numbers: M00575241 M00575281 M00575321 M00575361 M00575381 M00575401 M00575441 M00575481	500 units	Class II	Ongoing	23 Mar 2022
Z-0781-2022	RX CHOLANGIOGRAM KIT - SINGLE Material Number: M00575240 M00575240 M00575280 M00575320 M00575360 M00575380 M00575400 M00575440 M00575480	N/A	Class II	Ongoing	23 Mar 2022

openFDA, about the status: FDA does not update the status of a recall after the recall has been classified according to its level of hazard. As such, the status of a recall (open, completed, or terminated) will remain unchanged after published in the Enforcement Reports. Source: openFDA, Drug Recall Enforcement Reports, Disclaimer.

Enforcement report: The FDA publication that lists recalls. It has one record for each product of a recall.

Enforcement event: All the product records that have one FDA event number. This site shows one event on one page.

Class II: The middle of the three FDA recall classes.

The event in context

Device events that started in 2021: 900
Share of these events in Class II: 89%
Product records in this event: 31Median of the firm: 2
Events of the firm on the register: 162

Other events of the firm

Other FDA enforcement events of Boston Scientific Corporation
Initiated	Product (first record)	Type	Class	Records
6 Aug 2026	LUX-Dx, LUX-Dx II, LUX-Dx II+ Insertable Cardiac Monitor System, SERVER SW LAT CLARITY DS US, Model Number 7260, All Ver	Device	Class II	3
22 Jul 2026	Boston Scientific Corporation StoneSmart Connect Console Contents: (1) Power Cord, (1) Power Adaptor, (1)DVI Cable, (1)	Device	Class II	1
14 Jul 2026	OverStitch Suture Cinch, 1pk. Endoscopic tissue approximation device.	Device	Class II	2
9 Jul 2026	Boston Scientific ENROUTE Transcarotid Neuroprotection System, Material Number SR-200-NPS; Percutaneous catheter	Device	Class I	2
30 Jun 2026	Rapid Refill Continuous Injection System, UPN M00566001	Device	Class II	1
30 Jun 2026	Radial Jaw 4 Standard Capacity Biopsy Forceps with the following descriptions and UPN: 1. Radial Jaw 4 SC 240cm Box 20;	Device	Class II	3
19 Jun 2026	Boston Scientific TheraSphere 360 Y-90 Management Platform, Model Number M00139509001; Radiological Image Processing Sys	Device	Class II	1
11 Jun 2026	FARADRIVE Steerable Sheath Clear IDE, used to facilitate access to the vasculature and into the chambers of the heart, M	Device	Class II	4
11 Jun 2026	FARASTAR Ablation Generator EU, Pulsed Field Ablation Generator, Product ID 61M401; Percutaneous Cardiac Ablation Cathet	Device	Class II	3
11 Jun 2026	FARASTAR Ablation Generator EU, Pulsed Field Ablation Generator, Product ID 61M401; Percutaneous Cardiac Ablation Cathet	Device	Class II	1

Boston Scientific Corporation: all 162 events

Official channels

FDA enforcement report Z-0751-2022The FDA record of the first product of this event.
FDA: recalls, market withdrawals and safety alertsThe recall notices on the FDA site.
FDA MedWatchThe FDA safety reporting program for drugs and medical devices.

Follow by RSS:Food, drug and device recallsFDA Class I recalls

Cite this page

Recall Register. FDA enforcement event 89468. https://recallregister.com/fda/ii/89468/. Source: openFDA enforcement reports. Data through 28 Sep 2026.

Sources

Source: openFDA device enforcement reports
Licence: CC0 1.0
Export date: 28 Sep 2026
Newest FDA report date on the register: 23 Sep 2026

FDA has one record for each product. This site puts the records with the same event number on one page. The class of the event is the highest class of its records. How the register is made. Report an error.

Questions

Where was the product distributed?: The FDA record gives this distribution: Worldwide distribution - US Nationwide and the countries of Australia, Austria, Belgium, Canada, Botswana, China, Czech Republic, Denmark, Finland, France, Germany, Great Britain, Greece, Ireland,…
What quantity of product is in FDA event 89468?: The event has 31 product records. The first record gives this quantity: 21309 units
How did the recall start?: The FDA record says: Voluntary: Firm initiated
How many device recalls of 2021 have the same class?: 89% of the 900 device events that started in 2021 are in Class II.