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Nucletron B.V. Intrauterine Tube Recall - Tip Detachment

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Summary

Health Canada issued a Type II medical device recall for Nucletron B.V. Intrauterine Tubes (catalog numbers 152019-00 through 126015-01) affecting 44 product lots. The recall addresses a safety concern where the tip of the 4mm diameter IU tube detached and remained within a patient during use. Healthcare providers and facilities using these devices must stop use immediately and contact the manufacturer.

What changed

Health Canada issued a Type II medical device recall for Nucletron B.V. Intrauterine Tubes, affecting 44 catalog numbers (152019-00 through 126015-01). The safety concern involves the detachment of the tip of the 4mm diameter IU tube that remained within a patient during a medical procedure.\n\nHealthcare providers and facilities performing intrauterine procedures must immediately cease use of all affected products and contact the manufacturer at the provided email or phone number. Given the potential for serious patient harm including surgical complications from retained device fragments, this recall represents a significant patient safety matter requiring urgent attention from clinical staff and supply chain managers.

What to do next

  1. Stop using all affected Nucletron B.V. Intrauterine Tube catalog numbers immediately
  2. Contact manufacturer at APPLICATION.SUPPORT.NA@ELEKTA.COM or 1-855-693-5358
  3. Follow manufacturer instructions for return/disposition of affected devices

Archived snapshot

Apr 9, 2026

GovPing captured this document from the original source. If the source has since changed or been removed, this is the text as it existed at that time.

Health product recall

Nucletron B.V. Intrauterine Tube

Brand(s)

Nucletron B.V.

Last updated

2026-04-08

Summary

Product Nucletron B.V. Intrauterine Tube Issue Medical devices - Performance What to do Contact the manufacturer if you require additional information.

APPLICATION.SUPPORT.NA@ELEKTA.COM
TEL: +1 855 6935358
HTTPS://WWW.ELEKTA.COM

Audience Healthcare

Affected products

| Affected products | Lot or serial number | Model or catalogue number |
| --- | --- | --- |
| Intrauterine Tube | Not applicable. | 152019-00 |
| Intrauterine Tube | Not applicable. | 152021-00 |
| Intrauterine Tube | Not applicable. | 152008-00 |
| Intrauterine Tube | Not applicable. | 152015-00 |
| Intrauterine Tube | Not applicable. | 152018-00 |
| Intrauterine Tube | Not applicable. | 152005-00 |
| Intrauterine Tube | Not applicable. | 152007-00 |
| Intrauterine Tube | Not applicable. | 152012-00 |
| Intrauterine Tube | Not applicable. | 152014-00 |
| Intrauterine Tube | Not applicable. | 152009-00 |
| Intrauterine Tube | Not applicable. | 152010-00 |
| Intrauterine Tube | Not applicable. | 152011-00 |
| Intrauterine Tube | Not applicable. | 152013-00 |
| Intrauterine Tube | Not applicable. | 152016-00 |
| Intrauterine Tube | Not applicable. | 152020-00 |
| Intrauterine Tube | Not applicable. | 152022-00 |
| Intrauterine Tube | Not applicable. | 152017-00 |
| Intrauterine Tube | Not applicable. | 152023-00 |
| Intrauterine Tube | Not applicable. | 126014-01 |
| Intrauterine Tube | Not applicable. | 126019-00 |
| Intrauterine Tube | Not applicable. | 126016-01 |
| Intrauterine Tube | Not applicable. | 126020-00 |
| Intrauterine Tube | Not applicable. | 126020-01 |
| Intrauterine Tube | Not applicable. | 126021-01 |
| Intrauterine Tube | Not applicable. | 126016-00 |
| Intrauterine Tube | Not applicable. | 126017-00 |
| Intrauterine Tube | Not applicable. | 126017-01 |
| Intrauterine Tube | Not applicable. | 126018-01 |
| Intrauterine Tube | Not applicable. | 126023-00 |
| Intrauterine Tube | Not applicable. | 126023-01 |
| Intrauterine Tube | Not applicable. | 126013-01 |
| Intrauterine Tube | Not applicable. | 126014-00 |
| Intrauterine Tube | Not applicable. | 126018-00 |
| Intrauterine Tube | Not applicable. | 126013-00 |
| Intrauterine Tube | Not applicable. | 126015-00 |
| Intrauterine Tube | Not applicable. | 126021-00 |
| Intrauterine Tube | Not applicable. | 126022-00 |
| Intrauterine Tube | Not applicable. | 126022-01 |
| Intrauterine Tube | Not applicable. | 126015-01 |
| Intrauterine Tube | Not applicable. | 126019-01 |

Issue

Elekta are informing customers of a safety concern regarding the detachment of the tip of the Intrauterine Tube (IU tube) with a 4mm diameter that remained within a patient.

Additional information

Details

Original published date:

2026-04-08

Alert / recall type Health product recall Category Health products - Medical devices - Radiology Companies Nucletron B.V.

Waardgelder 1, Veenendaal, Netherlands, 3905 TH

Published by Health Canada Audience Healthcare Recall class Type II Recall date

2026-03-20

Identification number RA-81859

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Last updated

Classification

Agency
Health Canada
Filed
March 20th, 2026
Instrument
Enforcement
Legal weight
Binding
Stage
Final
Change scope
Substantive
Document ID
RA-81859

Who this affects

Applies to
Medical device makers Healthcare providers
Industry sector
3345 Medical Device Manufacturing
Activity scope
Medical device recall response Patient safety alert
Geographic scope
Canada CA

Taxonomy

Primary area
Medical Devices
Operational domain
Clinical Operations
Compliance frameworks
GxP
Topics
Pharmaceuticals Public Health

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