HT Connect Peripheral Guide Wire
Medical device recall Z-0558-2014. Published in FDA’s Enforcement Report on Jan 1, 2014.
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 Jan 1, 2014. Copied from openFDA on Oct 20, 2026.
- Class II FDA’s class
- Terminated its status, in FDA’s file
- Nationwide FDA’s word for where it went
- 54,895 units total (5,356 units in US) 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?
Abbott Vascular has initiated a recall of the HT Connect Peripheral Guide Wires due to a small number of devices exhibiting partial delamination of the PTFE coating.
FDA, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.
Which ones are recalled?
HT Connect Peripheral Guide Wire Part Number Description 1012587 018 HT CONNECT 145 CM 1012588 018 HT CONNECT 195 CM 1012589 018 HT CONNECT 300 CM 1012590 018 HT CONNECT FLEX 145 CM 1012591 018 HT CONNECT FLEX 195 CM 1012592 018 HT CONNECT FLEX 300 CM 1012593 018 HT CONNECT 250T 145 CM 1012594 018 HT CONNECT 250T 195 CM 1012595 018 HT CONNECT 250T 300 CM
54,895 units total (5,356 units in US), in FDA’s words.
FDA, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.
Codes to check against yours
Part Number Lot Number 1012587 10097079 1012587 10168703 1012587 10168705 1012587 10171679 1012587 10262897 1012587 10281944 1012587 10303349 1012587 90021507 1012588 10087171 1012588 10087179 1012588 10108128 1012588 10108132 1012588…
Every code shown here, 1,995 characters
Part Number Lot Number 1012587 10097079 1012587 10168703 1012587 10168705 1012587 10171679 1012587 10262897 1012587 10281944 1012587 10303349 1012587 90021507 1012588 10087171 1012588 10087179 1012588 10108128 1012588 10108132 1012588 10137054 1012588 10137224 1012588 10155636 1012588 10155638 1012588 10156982 1012588 10171681 1012588 10181960 1012588 10186395 1012588 10187173 1012588 10201046 1012588 10201050 1012588 10202457 1012588 10213592 1012588 10213593 1012588 10220279 1012588 10220283 1012588 10220284 1012588 10226194 1012588 10226314 1012588 10226315 1012588 10226316 1012588 10226317 1012588 10226318 1012588 10244104 1012588 10303351 1012588 10303361 1012588 90020420 1012588 90020746 1012588 90021060 1012588 90021154 1012588 90021155 1012588 90021156 1012588 90021266 1012588 90021313 1012588 90021334 1012588 90021335 1012588 90021508 1012588 90021509 1012588 90021573 1012589 10087172 1012589 10087180 1012589 10087181 1012589 10087182 1012589 10087183 1012589 10108129 1012589 10108133 1012589 10111356 1012589 10111357 1012589 10118216 1012589 10122343 1012589 10137056 1012589 10156973 1012589 10157066 1012589 10167663 1012589 10171682 1012589 10171702 1012589 10181961 1012589 10187172 1012589 10187174 1012589 10187189 1012589 10194671 1012589 10200648 1012589 10202451 1012589 10202452 1012589 10219309 1012589 10219349 1012589 10220313 1012589 10220314 1012589 10220317 1012589 10222768 1012589 10226195 1012589 10226313 1012589 10237343 1012589 10239255 1012589 10239256 1012589 10239258 1012589 10239259 1012589 10265833 1012589 10281945 1012589 10281948 1012589 10288067 1012589 10294349 1012589 10294350 1012589 10298877 1012589 10300028 1012589 10303355 1012589 10303363 1012589 10303365 1012589 10305105 1012589 10305106 1012589 10309225 1012589 10309238 1012589 90020421 1012589 90020747 1012589 90020926 1012589 90021276 1012589 90021277 1012589 90021278 1012589 90021279 1012589 90021388 1012589 90021389 1012589 90021484 1012589 90021485 1012589 90021486…
FDA’s list runs to 4,510 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 Distribution - USA (nationwide) and Internationally to Australia, French Guyana, Macedonia, South Korea, Austria, Germany, Malaysia, Spain, Bahrain, Greece, Martinique, Sweden, Belgium, Hong Kong, Netherlands, Switzerland, Brazil, Indonesia, New Zealand, Taiwan, Bulgaria, Iran, Norway, Thailand, Canada, Iraq, Poland, Turkey, China, Ireland, Portugal, United Arab Emirates, Czech Republic, Italy, Saudi Arabia, United Kingdom, Denmark, Latvia, Singapore, Estonia, Libya, Slovakia, Finland, Lithuania, Slovenia, France, Luxembourg, South Africa.
These words name no state.
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 Nov 25, 2013.
- FDA classified it on Dec 20, 2013.
- FDA’s Enforcement Report published it on Jan 1, 2014.
- FDA terminated it on Jul 14, 2014.
FDA, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.
Who is recalling it?
- Abbott Vascular, Inc., of Temecula, CA.
- 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 4,510 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
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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.