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Boston Scientific pulls all Imager II catheters after tip-manufacturing defect

Boston Scientific pulls all Imager II catheters after tip-manufacturing defect

Rule Changes

Two serious injuries reported; company discontinues the product line rather than fix the issue

September 3rd, 2026: Recall becomes public news

Overview

Updated Sep 3

Boston Scientific told hospitals to stop using every Imager II Angiographic Catheter it has sold. The tips were made with too little stabilizing agent, which raises the risk they could degrade and detach inside a patient's blood vessel.

Two patients have been seriously injured as of July 16. The company chose to discontinue the product entirely rather than correct the manufacturing problem, and the Food and Drug Administration (FDA) posted an Early Alert in early September 2026.

Why it matters

If a catheter tip detaches in a patient's artery, the fragment can block blood flow and trigger a life-threatening embolism — and every Imager II unit ever sold is now being pulled from shelves.

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Key Indicators

2
Serious injuries reported as of July 16, 2026
Injuries tied to catheter tip detachment, per the FDA Early Alert.
100%
Share of Imager II inventory pulled
All lots of the product line are subject to removal from use and distribution.
6,130
Catheters in the prior 2020 Imager II recall
An earlier, separate recall of the same product family involved 9 reported injuries.

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People Involved

Organizations Involved

Timeline

July 2026 September 2026

4 events Latest: September 3rd, 2026 · 1 week ago
Tap a bar to jump to that date
  1. Recall becomes public news

    Latest Media Report

    Trade and business outlets report that Boston Scientific halted sales of the catheters.

  2. FDA issues Early Alert

    Regulatory

    FDA publicizes the potentially high-risk device issue and Boston Scientific's removal decision.

  3. Boston Scientific sends recall letter

    Recall Action

    Company tells customers to stop using and distributing all Imager II catheters, verify inventory by UPN, and return product.

  4. Two serious injuries on record

    Safety Data

    Boston Scientific reports two serious injuries tied to the tip issue; no deaths.

Scenarios

1

Recall runs to completion, no new injuries

Likely Resolves by Q1 2027

Discussed by: MedTech Dive, FDA monitoring

Hospitals return affected inventory, Boston Scientific processes the returns, and the FDA closes the file with no additional reported injuries. The discontinuation stands, and physicians switch to alternative angiographic catheters from other manufacturers, which remain widely available.

2

FDA escalates to formal Class I recall

Possible Resolves by End of 2026

Discussed by: MassDevice, FDA Early Alert framework

The FDA assigns a formal recall classification, potentially Class I (the most serious), given the risk of life-threatening embolism. This would trigger broader public notification and possibly a longer compliance review of how Boston Scientific handled the removal.

3

New injuries or litigation surface

Unlikely Resolves by Q2 2027

Discussed by: PharmaDeviceNews, patient-safety trackers

Additional reports of tip detachment emerge as hospitals audit their inventory and review patient records. If more injuries appear, plaintiff attorneys may pursue product-liability claims against Boston Scientific, and the FDA could demand corrective-action plans beyond the current discontinuation.

Historical Context

2 moments from history that rhyme with this story — and how they unfolded.

February 2020

Imager II recall (2020)

Boston Scientific recalled 6,130 Imager II 5F Angiographic Catheters distributed between July 2018 and November 2019 after nine people were injured by a faulty catheter tip. The tips could detach during a procedure or during procedure preparation.

Then

The FDA flagged risks of additional surgery to remove the detached tip, embolism, stroke, or death.

Now

The 2020 recall established a pattern: this product family had tip-integrity problems years before the 2026 removal.

Why this matters now

The same catheter family is now the subject of a market-wide removal, showing a recurring manufacturing vulnerability rather than an isolated batch defect.

Summer 2026

Silk Road Medical catheter removal (2026)

Earlier in the same year, Boston Scientific removed another catheter from the market over a tip-separation risk. That product was part of a stroke-prevention system made by Silk Road Medical, which Boston Scientific acquired in 2024.

Then

The device was pulled shortly after the acquisition, raising questions about the acquired product line's quality controls.

Now

Two tip-related removals in one year pressure Boston Scientific's quality-management reputation.

Why this matters now

It shows 2026 was a difficult year for Boston Scientific's catheter quality, with two separate products removed for tip-integrity failures.

Sources

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