Boston Scientific Guider Softip XF Guide Catheter Product Usage: Is a neurovascular access catheter that…
Medical device recall Z-2735-2018. Published in FDA’s Enforcement Report on Aug 15, 2018.
No Watch here, and no alerts: openFDA asks that its enforcement data “should not be used as a method to collect data to issue alerts to the public, nor should it be used to track the lifecycle of a recall” (openFDA). For FDA’s own recall emails, subscribe at FDA. FDA’s own record is on accessdata.fda.gov.
The short answer
Published in FDA’s Enforcement Report on Aug 15, 2018. Copied from openFDA on Oct 20, 2026.
- Class II FDA’s class
- Terminated its status, in FDA’s file
- Nationwide FDA’s word, and 18 states named
- 31,005 how much, in FDA’s words
Every line below is in FDA’s own words, with its source beside it. FDA’s terms are explained in FDA’s own words.
How serious is it, by FDA’s class?
Class II, the middle of FDA’s three classes.
“Products that might cause a temporary health problem, or pose only a slight threat of a serious nature. Example: a drug that is under-strength but that is not used to treat life-threatening situations.”
openFDA, in plain words, its enforcement report fields.
“Class II is 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.”
FDA’s rule, 21 CFR 7.3(m)(2), eCFR.
What these words mean is quoted from openFDA’s field reference and 21 CFR 7.3.
What’s wrong with it?
Potential polymer material degradation.
FDA, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.
Which ones are recalled?
Boston Scientific Guider Softip XF Guide Catheter Product Usage: Is a neurovascular access catheter that creates a stable conduit through which interventional devices can pass. It is constructed with a polymer liner on the inside diameter for lubricity, stainless steel wire reinforcement within the wall for torque transmission and strength, and polymer materials along the length of the catheter for support and flexibility. The catheter has an atraumatic tip and a hub/strain relief combination for kink resistance (at the hub), device connectivity, and device handling.
31,005, in FDA’s words.
FDA, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.
Codes to check against yours
Product Batch GUIDER/40DEG XF/7FR/90CM 17987235 GUIDER/40DEG XF/7FR/90CM 17997088 GUIDER/40DEG XF/7FR/90CM 18056237 GUIDER/40DEG XF/7FR/90CM 18056695 GUIDER/40DEG XF/7FR/90CM 18056772 GUIDER/40DEG XF/7FR/90CM 18070824 GUIDER/40DEG…
Every code shown here, 1,999 characters
Product Batch GUIDER/40DEG XF/7FR/90CM 17987235 GUIDER/40DEG XF/7FR/90CM 17997088 GUIDER/40DEG XF/7FR/90CM 18056237 GUIDER/40DEG XF/7FR/90CM 18056695 GUIDER/40DEG XF/7FR/90CM 18056772 GUIDER/40DEG XF/7FR/90CM 18070824 GUIDER/40DEG XF/7FR/90CM 18070877 GUIDER/40DEG XF/7FR/90CM 18080732 GUIDER/40DEG XF/7FR/90CM 18081509 GUIDER/40DEG XF/7FR/90CM 18082040 GUIDER/40DEG XF/7FR/90CM 18082155 GUIDER/40DEG XF/7FR/90CM 18090719 GUIDER/40DEG XF/7FR/90CM 18091068 GUIDER/40DEG XF/7FR/90CM 18091155 GUIDER/40DEG XF/7FR/90CM 18092066 GUIDER/40DEG XF/7FR/90CM 18098344 GUIDER/40DEG XF/7FR/90CM 18098359 GUIDER/40DEG XF/7FR/90CM 18106676 GUIDER/40DEG XF/7FR/90CM 18107079 GUIDER/40DEG XF/7FR/90CM 18107320 GUIDER/40DEG XF/7FR/90CM 18107526 GUIDER/40DEG XF/7FR/90CM 18116096 GUIDER/40DEG XF/7FR/90CM 18116710 GUIDER/40DEG XF/7FR/90CM 18122629 GUIDER/40DEG XF/7FR/90CM 18122904 GUIDER/40DEG XF/7FR/90CM 18123050 GUIDER/40DEG XF/7FR/90CM 18123182 GUIDER/40DEG XF/7FR/90CM 18194574 GUIDER/40DEG XF/7FR/90CM 18194635 GUIDER/40DEG XF/7FR/90CM 18318478 GUIDER/40DEG XF/7FR/90CM 18504666 GUIDER/40DEG XF/7FR/90CM 18638010 GUIDER/40DEG XF/7FR/90CM 18672575 GUIDER/40DEG XF/7FR/90CM 18674120 GUIDER/40DEG XF/7FR/90CM 18707488 GUIDER/40DEG XF/7FR/90CM 18708083 GUIDER/40DEG XF/7FR/90CM 18708427 GUIDER/40DEG XF/7FR/90CM 18709130 GUIDER/40DEG XF/7FR/90CM 18709234 GUIDER/40DEG XF/7FR/90CM 18709643 GUIDER/40DEG XF/7FR/90CM 18711978 GUIDER/40DEG XF/7FR/90CM 18774426 GUIDER/40DEG XF/7FR/90CM 18774597 GUIDER/40DEG XF/7FR/90CM 18774858 GUIDER/40DEG XF/7FR/90CM 18775292 GUIDER/40DEG XF/7FR/90CM 18785135 GUIDER/40DEG XF/7FR/90CM 18785166 GUIDER/40DEG XF/7FR/90CM 18785727 GUIDER/40DEG XF/7FR/90CM 18785933 GUIDER/40DEG XF/7FR/90CM 18836128 GUIDER/40DEG XF/7FR/90CM 18837164 GUIDER/40DEG XF/7FR/90CM 18837319 GUIDER/40DEG XF/7FR/90CM 18837363 GUIDER/40DEG XF/7FR/90CM 18849986 GUIDER/40DEG XF/7FR/90CM 18853195 GUIDER/40DEG XF/7FR/90CM 18932474 GUIDER/40DEG XF/7FR/90CM 19545073 GUIDER/40DEG XF/7FR/90CM 19545475 GUIDER/40DEG…
FDA’s list runs to 24,036 characters. The first part is shown; the rest is on FDA’s record.
Copied exactly as FDA lists them: lot and serial numbers, dates and other codes on the product or its label.
Where did it go?
FDA’s words for the “general area of initial distribution”: where the firm first shipped it.
Worldwide - US Nationwide Distribution - AL, FL, IL, IN, KY, MA, MI, MN, MS, NC, NV, NY, OH, OR, TN, TX, UT, WA and the country CANADA
The states and territories these words name
18 states and territories.
Every one of them
- Alabama
- Florida
- Illinois
- Indiana
- Kentucky
- Massachusetts
- Michigan
- Minnesota
- Mississippi
- North Carolina
- Nevada
- New York
- Ohio
- Oregon
- Tennessee
- Texas
- Utah
- Washington
What FDA means by nationwide
“The term “nationwide” is defined to mean the fifty states or a significant portion. Note that subsequent distribution by the consignees to other parties may not be included.”
openFDA, its enforcement report fields.
The words say it went outside the United States too.
What these words mean is quoted from openFDA’s field reference and 21 CFR 7.3.
Is it still going on?
Terminated, in FDA’s file.
“FDA has determined that all reasonable efforts have been made to remove or correct the violative product in accordance with the recall strategy, and proper disposition has been made according to the degree of hazard.”
openFDA, on “Terminated”, its enforcement report fields.
What these words mean is quoted from openFDA’s field reference and 21 CFR 7.3.
- The firm began the recall on Dec 11, 2017.
- FDA classified it on Aug 8, 2018.
- FDA’s Enforcement Report published it on Aug 15, 2018.
- FDA terminated it on Nov 4, 2019.
FDA, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.
Who is recalling it?
- Boston Scientific Corporation, of Maple Grove, MN.
- Who began it, in FDA’s words: Voluntary: Firm initiated.
- How the firm first told its customers: Letter.
FDA, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.
What this record can’t tell you
- Whether your own one is affected: compare the codes, dates and numbers above with yours. When unsure, ask the firm or the store.
- Where it went after the firm’s first shipments. FDA’s words cover the firm’s initial distribution, and, in FDA’s words, “subsequent distribution by the consignees to other parties may not be included.”
- How many have been returned, corrected or destroyed: FDA’s report doesn’t say.
- Whether anyone was hurt or fell ill: the report doesn’t say.
- How current it is: openFDA publishes FDA’s Enforcement Report weekly, after FDA does, and a firm can announce a recall weeks before it appears there. openFDA’s own caution: “This data should not be used as a method to collect data to issue alerts to the public, nor should it be used to track the lifecycle of a recall.”
- FDA’s list of codes runs to 24,036 characters; the first part is shown here, and the rest is on FDA’s record.
- A product with no recall here isn’t safe by that: FDA’s report lists the recalls FDA classified, and when.
Hearth Record wrote these lines; the quotations are FDA’s.
Sources
-
U.S. Food and Drug Administration, Device recall enforcement reports.
Released Oct 14, 2026 and checked Oct 20, 2026. Updated weekly. Public domain (CC0 1.0, openFDA). FDA asks that nothing suggest it endorses this site.
Recalls of food, medicines, medical devices, pet food and animal drugs are from the U.S. Food and Drug Administration (FDA). FDA does not endorse Hearth Record. openFDA: “Do not rely on openFDA to make decisions regarding medical care.” Copied on Oct 20, 2026.